Publications by authors named "Jean Claude Souberbielle"

204 Publications

Cholecalciferol (vitamin D3) must not be considered as an endocrine disruptor

Geriatr Psychol Neuropsychiatr Vieil 2022 06;20(2):151-161

Membre du bureau et du Conseil scientifique de la Société française de gériatrie et gérontologie, Département de gériatrie et Centre mémoire ressources recherche, Centre de recherche sur l’autonomie et la longévité, Centre hospitalier universitaire, Angers, France ; UNIV ANGERS, UPRES EA 4638, Université d’Angers, Angers, France ; Gérontopôle Autonomie Longévité des Pays de la Loire, Nantes, France

A French ministerial decree planning to include cholecalciferol, i.e. vitamin D3 (VD3), in the endocrine disruptors (ED) list has generated a lot of concerns in French physicians and scientists. The aim of the present article was to discuss the scientific rationale that may support or not this decision, which seems to be due to the use of VD3 overdose as a rodenticide in some European countries. First, it is noticeable that cholecalciferol is not an “exogenous substance”, a term used in all the definitions of ED, as it is largely synthesized in the skin after UVB rays exposure. Second, we did not find any published article that may support the inclusion of VD3 in the ED list. The request “vitamin D AND endocrine disruptor” reported 33 references in the PubMed database on March, 10, 2022, most of them discussing disturbances of vitamin D metabolism by EDs. Third, a large amount of studies conclude that VD3 has or may have beneficial effects on many functions that are known to be altered by EDs. In addition, we warn that learning that VD3 could be legally considered as a PE may cause the general public to mistrust vitamin D supplementation, which is not desirable in terms of public health as it may increase the already too high prevalence of vitamin D deficient individuals. We consider the aberrant decision of including cholecalciferol in the ED list should be rapidly invalidated before being effective in France and possibly disseminated in the European Union.
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http://dx.doi.org/10.1684/pnv.2022.1031DOI Listing
June 2022

IGF-I variability over repeated measures in patients with acromegaly under long-acting somatostatin receptor ligands.

J Clin Endocrinol Metab 2022 Jul 1. Epub 2022 Jul 1.

Université Paris-Saclay, Inserm, Physiologie et Physiopathologie Endocriniennes, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction, Le Kremlin-Bicêtre, France.

Context: In patients with acromegaly on long-term treatment with long-acting somatostatin receptor ligands (SRLs), the time of blood collection for IGF-I measurement after injection is not well defined.

Aim: To assess serum IGF-I dynamics and variability in SRL-treated patients compared with surgically cured patients and healthy controls.

Patients And Methods: Thirty patients under SRLs considered controlled based on a normal previous IGF-I level, ten patients cured by pituitary surgery, and seven healthy subjects underwent four IGF-I weekly determinations.

Results: In SRL-treated patients, the IGF-I SDS (mean±SD) was higher just before injection (0.34±0.66) than at Day 7 (-0.33±0.61; p=0.0041) and Day 14 (-0.23±0.60; p=0.047) after injection, but it did not significantly vary in cured patients and healthy controls. The IGF-I CV was higher in SRL-treated patients than in cured patients or healthy controls (14.4±7.6% vs. 7.9±4.4% and 8.3±3.2%, respectively; p<0.05 for both). Among SRL-treated patients, IGF-I CV was higher in "nonoptimally controlled patients"-i.e., patients with at least one elevated IGF-I value out of four (n=9) compared with "optimally controlled" patients for whom all four IGF-I SDS values were <2.0 (21.3±9.3 vs. 11.6±6.0%; p=0.0019). The latter did not differ from surgically cured patients and healthy controls. The measurement at the farthest distance from the SRL injection was the most predictive of patients with nonoptimally controlled disease.

Conclusions: In patients treated with long-acting SRLs, IGF-I sampling at the farthest distance from SRL injection is the most informative and best predictor of optimal disease control.
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http://dx.doi.org/10.1210/clinem/dgac385DOI Listing
July 2022

High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial.

PLoS Med 2022 05 31;19(5):e1003999. Epub 2022 May 31.

Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France; Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France.

Background: Vitamin D supplementation has been proposed as a treatment for Coronavirus Disease 2019 (COVID-19) based on experimental data and data from small and uncontrolled observational studies. The COvid19 and VITamin d TRIAL (COVIT-TRIAL) study was conducted to test whether a single oral high dose of cholecalciferol (vitamin D3) administered within 72 hours after the diagnosis of COVID-19 improves, compared to standard-dose cholecalciferol, the 14-day overall survival among at-risk older adults infected with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Methods And Findings: This multicenter, randomized, controlled, open-label, superiority trial involved collaboration of 9 medical centers in France. Patients admitted to the hospital units or living in nursing homes adjacent to the investigator centers were eligible if they were ≥65 years, had SARS-CoV-2 infection of less than 3 days, and at least 1 COVID-19 worsening risk factor (among age ≥75 years, SpO2 ≤94%, or PaO2/FiO2 ≤300 mm Hg). Main noninclusion criteria were organ failure requiring ICU, SpO2 ≤92% despite 5 L/min oxygen, life expectancy <3 months, vitamin D supplementation >800 IU/day during the preceding month, and contraindications to vitamin D supplements. Eligible and consenting patients were randomly allocated to either a single oral high-dose (400,000 IU) or standard-dose (50,000 IU) cholecalciferol administered under medical supervision within 72 hours after the diagnosis of COVID-19. Participants and local study staff were not masked to the allocated treatment, but the Steering Committee and the Data and Safety Monitoring Board were masked to the randomization group and outcome data during the trial. The primary outcome was 14-day overall mortality. Between April 15 and December 17, 2020, of 1,207 patients who were assessed for eligibility in the COVIT-TRIAL study, 254 met eligibility criteria and formed the intention-to-treat population. The median age was 88 (IQR, 82 to 92) years, and 148 patients (58%) were women. Overall, 8 (6%) of 127 patients allocated to high-dose cholecalciferol, and 14 (11%) of 127 patients allocated to standard-dose cholecalciferol died within 14 days (adjusted hazard ratio = 0.39 [95% confidence interval [CI], 0.16 to 0.99], P = 0.049, after controlling for randomization strata [i.e., age, oxygen requirement, hospitalization, use of antibiotics, anti-infective drugs, and/or corticosteroids] and baseline imbalances in important prognostic factors [i.e., sex, ongoing cancers, profuse diarrhea, and delirium at baseline]). The number needed to treat for one person to benefit (NNTB) was 21 [NNTB 9 to ∞ to number needed to treat for one person to harm (NNTH) 46]. Apparent benefits were also found on 14-day mortality due to COVID-19 (7 (6%) deaths in high-dose group and 14 (11%) deaths in standard-dose group; adjusted hazard ratio = 0.33 [95% CI, 0.12 to 0.86], P = 0.02). The protective effect of the single oral high-dose administration was not sustained at 28 days (19 (15%) deaths in high-dose group and 21 (17%) deaths in standard-dose group; adjusted hazard ratio = 0.70 [95% CI, 0.36 to 1.36], P = 0.29). High-dose cholecalciferol did not result in more frequent adverse effects compared to the standard dose. The open-label design and limited study power are the main limitations of the study.

Conclusions: In this randomized controlled trial (RCT), we observed that the early administration of high-dose versus standard-dose vitamin D3 to at-risk older patients with COVID-19 improved overall mortality at day 14. The effect was no longer observed after 28 days.

Trial Registration: ClinicalTrials.gov NCT04344041.
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http://dx.doi.org/10.1371/journal.pmed.1003999DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9154122PMC
May 2022

Bone Fragility in Chronic Kidney Disease Stage 3 to 5: The Use of Vitamin D Supplementation.

Metabolites 2022 Mar 20;12(3). Epub 2022 Mar 20.

Bioscar INSERM U1132, Department of Rheumatology, Université de Paris, Hôpital Lariboisière, 75010 Paris, France.

Frequently silent until advanced stages, bone fragility associated with chronic kidney disease-mineral and bone disease (CKD-MBD) is one of the most devastating complications of CKD. Its pathophysiology includes the reduction of active vitamin D metabolites, phosphate accumulation, decreased intestinal calcium absorption, renal alpha klotho production, and elevated fibroblast growth factor 23 (FGF23) levels. Altogether, these factors contribute firstly to secondary hyperparathyroidism, and ultimately, to micro- and macrostructural bone changes, which lead to low bone mineral density and an increased risk of fracture. A vitamin D deficiency is common in CKD patients, and low circulating 25(OH)D levels are invariably associated with high serum parathyroid hormone (PTH) levels as well as with bone mineralization defects, such as osteomalacia in case of severe forms. It is also associated with a variety of non-skeletal diseases, including cardiovascular disease, diabetes mellitus, multiple sclerosis, cancer, and reduced immunological response. Current international guidelines recommend supplementing CKD patients with nutritional vitamin D as in the general population; however, there is no randomized clinical trial (RCT) evaluating the effect of vitamin D (or vitamin D+calcium) supplementation on the risk of fracture in the setting of CKD. It is also unknown what level of circulating 25(OH)D would be sufficient to prevent bone abnormalities and fractures in these patients. The impact of vitamin D supplementation on other surrogate endpoints, including bone mineral density and bone-related circulating biomarkers (PTH, FGF23, bone-specific alkaline phosphatase, sclerostin) has been evaluated in several RTCs; however, the results were not always translated into an improvement in long-term outcomes, such as reduced fracture risk. This review provides a brief and comprehensive update on CKD-related bone fragility and the use of natural vitamin D supplementation in these patients.
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http://dx.doi.org/10.3390/metabo12030266DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8953916PMC
March 2022

Vitamin D supplementation and COVID-19: expert consensus and guidelines.

Geriatr Psychol Neuropsychiatr Vieil 2021 Oct 5. Epub 2021 Oct 5.

Service des explorations fonctionnelles, Hôpital Necker-Enfants malades, AP-HP Paris, France.

After 12 months of viral circulation, the SARS-CoV-2 has infected millions of people around the world, leaving hundreds of thousands dead. Given the lack of effective therapy and vaccination against COVID-19, focusing on the immediate repurposing of existing drugs gives some hope of curbing the pandemic. Vitamin D is a possible candidate drug which is discussed in a high number of publications. Randomised clinical trials have shown that vitamin D supplementation significantly reduces the risk of respiratory infections. There is also a great deal of evidence that hypovitaminosis D is an independent (and easily modifiable) risk factor for severe forms of COVID-19 and death. Vitamin D supplementation is a simple, safe and inexpensive measure, which is effective in correcting hypovitaminosis D, present in 40-50% of the French population and in more than 80% of adults with COVID-19. In this position paper, we propose simple regimens (adapted to the pharmaceutical forms currently available in France) for vitamin D supplementation in adults with or without COVID-19.
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http://dx.doi.org/10.1684/pnv.2021.0955DOI Listing
October 2021

Reference values for IGF-I serum concentration in an adult population: use of the VARIETE cohort for two new immunoassays.

Endocr Connect 2021 Aug 26;10(9):1027-1034. Epub 2021 Aug 26.

Université Paris-Saclay, Inserm, Physiologie et Physiopathologie Endocriniennes, Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction, Centre de Référence des Maladies Rares de l'Hypophyse, Le Kremlin-Bicêtre, France.

Objective: Measurement of IGF-I is important in the management of patients with growth hormone disorders. Here we aim to establish normative data for two new IGF-I assay kits based on a large random sample of the French general adult population.

Subjects And Methods: We measured IGF-I in 911 healthy adults (18-90 years) with two immunoassays (ROCHE Elecsys® and IMMULITE-2000 calibrated against the new IS 02/2547). We compared the data with those of the six immunoassays (iSYS, LIAISON XL, IMMULITE-2000 calibrated against the first IS 87/518, IGF-I RIACT, Mediagnost ELISA, and Mediagnost RIA) that we reported previously. The pairwise concordance among the eight assays was assessed with Bland-Altman plots for both the IGF-1 raw data and the standard deviation scores (SDS), as well as with the percentage of observed agreement and the weighted Kappa coefficient for categorizing IGF-I SDS (ClinicalTrials.gov Identifier: NCT01831648).

Results: The normative data included the range of values (2.5-97.5 percentiles) given by the two new IGF-I assays according to age group and sex. A formula for the SDS calculation is provided. As for the previous six assays, the lower limits of the reference intervals of the two new assays were similar, but the upper limits varied markedly. The pairwise concordances were only moderate (kappa 0.57).

Conclusions: Data obtained for these two new IGF-I immunoassays confirm that despite being obtained in the same large healthy population, the reference intervals of the eight commercial IGF-1 assay kits showed noteworthy differences. The agreement among the various methods was moderate to good.
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http://dx.doi.org/10.1530/EC-21-0175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8428081PMC
August 2021

Learning from previous methodological pitfalls to propose well-designed trials on vitamin D in COVID-19.

J Steroid Biochem Mol Biol 2021 07 14;211:105901. Epub 2021 Apr 14.

Service des explorations fonctionnelles, hôpital Necker-Enfants malades, Assistance Publique-Hôpitaux de Paris, 75015, Paris, France.

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http://dx.doi.org/10.1016/j.jsbmb.2021.105901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8045428PMC
July 2021

Bone Status According to Neurofibromatosis Type 1 Phenotype: A Descriptive Study of 60 Women in France.

Calcif Tissue Int 2021 06 8;108(6):738-745. Epub 2021 Feb 8.

Rhumatologie, Hôpital Henri Mondor, 51 Avenue du Maréchal de Lattre de Tassigny, 94010, Créteil, France.

There is an increased risk of osteoporosis and an abnormal bone turn over in neurofibromatosis 1 (NF1). Our objective is to evaluate bone status in NF1 and to look for associations with cutaneous phenotype. We conducted a descriptive, monocentric study. We included 60 NF1 women, 18-51 years old, non-menopausal, divided in 2 groups: «at risk phenotype» (ARP) composed by 30 patients with at least 2 subcutaneous neurofibromas (SC-NF) and «classical phenotype» (CP) composed by 30 patients with none or 1 SC-NF. We evaluated low bone mineral density (BMD) risk factors and measured BMD, calcium and phosphorus homeostasis and bone turnover markers. Before 50 years old, Z-score has to be used to assess BMD. Z-score < - 2 is below expected range and represents 2.5% of the population. There was no difference between the two groups. Overall, Z-scores were low and 5 patients had a Z-score < - 2 (8.3%), which is 3 times general population low BMD frequency. 10 fragility fractures occurred in 8 patients, among which 2 were vertebral fractures. 85% had low calcium intake. 12 patients had hypophosphoremia, 25 elevated PTH. Vitamin D levels were low for 86.4%. 41 patients (69.5%) had at least one abnormal bone turnover markers. Low BMD is 3.3 times more frequent in NF1 than in general population, with high fracture risk, regardless of the skin phenotype, classical or at risk, because of high bone turn over and secondary hyperparathyroidism due to vitamin D deficiency and poor calcium intake.
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http://dx.doi.org/10.1007/s00223-021-00807-6DOI Listing
June 2021

[Vitamin D supplementation and COVID-19: expert consensus and guidelines].

Geriatr Psychol Neuropsychiatr Vieil 2021 Mar;19(1):20-29

Service des explorations fonctionnelles, Hôpital Necker-Enfants malades, AP-HP, Paris, France.

After 12 months of viral circulation, the SARS-CoV-2 has infected millions of people around the world, leaving hundreds of thousands dead. With the lack of effective therapy and vaccination against COVID-19, focusing on the immediate repurposing of existing drugs gives hope of curbing the pandemic. Vitamin D is a possible candidate discussed in a high amount of publications. Randomized clinical trials show that vitamin D supplementation significantly reduces the risk of respiratory infections. There are also many evidences that hypovitaminosis D is an independent (and easily modifiable) risk factor for severe forms of COVID-19 and death. Vitamin D supplementation is a simple, safe and inexpensive measure, which is effective in correcting hypovitaminosis D found in 40-50% of the French population and in more than 80% of adults with COVID-19. In this position paper, we propose simple regimens (adapted to the pharmaceutical forms currently available in France) for vitamin D supplementation in adults with or without COVID-19.
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http://dx.doi.org/10.1684/pnv.2020.0907DOI Listing
March 2021

Vitamin D and pregnancy outcomes: Overall results of the FEPED study.

J Gynecol Obstet Hum Reprod 2020 Oct 27;49(8):101883. Epub 2020 Jul 27.

Service de Gynécologie-Obstétrique, Hôpital Antoine Béclère, Assistance Publique des Hôpitaux de Paris, Université Paris Saclay, Clamart, France.

Vitamin D insufficiency is highly prevalent in children and adults including pregnant women. During pregnancy, maternal vitamin D insufficiency could increase risks of several pregnancy complications and adverse birth outcomes. The FEPED study was designed to assess the effects of maternal vitamin D status in the first trimester during pregnancy on risks of preeclampsia, gestational diabetes mellitus (GDM), preterm birth and small-for-gestational age (SGA) at birth. This observational prospective cohort included 3129 women with a singleton pregnancy between April 2012 and July 2014 in six maternity units in France and Belgium. The aim of this review is to summarize the results of the FEPED study. At the first trimester the mean 25(OH)D concentration was 21.9 ± 10.4 ng/mL and 25(OH)D concentration was <20 ng/mL in 46.5 % of patients. After matching 83 cases of preeclampsia with 319 controls, a significant decrease in the risk of preeclampsia was associated with maternal vitamin D levels ≥ 30 ng/mL in the third trimesters (OR = 0.34; 95 % CI: 0.13-0.86. P = 0.023). In the first trimester, the risk for preeclampsia was decreased in these patients, but did not achieve statistical significance (OR = 0.57 95 % CI, 0.30-1.01; p = 0.09). For the 250 cases with GDM matched with 941 controls, no linear relationship was found between GDM and 25OHD levels in the first trimester of pregnancy. Finally, 2813 pregnant women were included in analyses of risks of preterm and SGA birth. No association was found between low maternal vitamin D levels in the first trimester and the risks of preterm birth (aOR = 1.53; 95 % CI: 0.97-2.43) or SGA (aOR = 1.07; 95 % CI: 0.75-1.54). Further investigation is needed to understand the mechanisms behind the association between vitamin D and birth outcomes.
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http://dx.doi.org/10.1016/j.jogoh.2020.101883DOI Listing
October 2020

FGF23 measurement in burosumab-treated patients: an emerging treatment may induce a new analytical interference.

Clin Chem Lab Med 2020 10;58(11):e267-e269

AP-HP, Department of Endocrinology and Diabetology for children and Department of Adolescent Medicine, Reference Center for Rare Disorders of the Calcium and Phosphate Metabolism, Filière OSCAR and Platform of Expertise for Rare Diseases Paris-Sud, Bicêtre Paris-Saclay Hospital, Paris Saclay University, Le Kremlin-Bicêtre, France.

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http://dx.doi.org/10.1515/cclm-2020-0460DOI Listing
October 2020

Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study.

Clin Nutr 2021 01 25;40(1):79-86. Epub 2020 Apr 25.

Gynécologie-Obstétrique, Hôpital Antoine-Béclère, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Sud, Clamart, France; Fondation PremUp, Paris, France.

Background & Aims: Gestational diabetes mellitus (GDM) is one of the most frequent medical complications during pregnancy. It has been associated with many adverse pregnancy, fetal and neonatal outcomes, as well as with an increased risk for mothers and children in the long term. There is a growing interest in vitamin D and its potential role in the development of metabolic disorders. However, the medical literature is not consensual. The aim of this study was to assess the risk of GDM according to vitamin D status during the first trimester.

Methods: This study is a nested case-control study performed from a multicenter prospective observational cohort of pregnant women assessed for 25-hydroxyvitamin D levels (25OHD). Three hundred ninety-three patients were included in the initial cohort. After applying exclusion criteria, a total of 1191 pregnant women were included. Two hundred fifty women with GDM (cases) were matched to 941 women without GDM (controls) for parity, age, body mass index before pregnancy, the season of conception, and phototype. This study was funded by a grant from the "Programme Hospitalier de Recherche Publique 2010".

Results: The GDM risk was significantly greater for patients with 25OHD levels <20 ng/mL (OR = 1∙42, 95% CI 1∙06-1∙91; p = 0∙021). However, there was no significant relationship with other thresholds. The study of 25OHD levels with the more precise cutting of 5 units intervals showed a variable relationship with GDM risk, as the risk was low for very low 25OHD levels, increased for moderated levels, decreased for normal levels, and finally increased for higher levels.

Conclusion: According to our study, there seems to be no linear relationship between GDM and 25OHD levels in the first trimester of pregnancy since GDM risk does not continuously decrease as 25OHD concentrations increase. Our results most probably highlight the absence of an association between 25OHD levels and GDM risk.
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http://dx.doi.org/10.1016/j.clnu.2020.04.028DOI Listing
January 2021

First Trimester Maternal Vitamin D Status and Risks of Preterm Birth and Small-For-Gestational Age.

Nutrients 2019 Dec 13;11(12). Epub 2019 Dec 13.

Department of Obstetrics and Gynaecology, Antoine Béclère Hospital, AP-HP, University Paris Saclay, F-92140 Clamart, France.

Maternal 25-hydroxyvitamin D (25-OHD) deficiency during pregnancy may increase the risk of preterm and small-for-gestational age (SGA) birth, but studies report conflicting results. We used a multicenter prospective cohort of 2813 pregnant women assessed for 25-OHD levels in the first trimester of pregnancy to investigate the association between maternal 25-OHD concentrations and risks of preterm birth (<37 weeks) and SGA (birthweight <10th percentile). Odds ratios were adjusted (aOR) for potential cofounders overall and among women with light and dark skin separately, based on the Fitzpatrick scale. 25-OHD concentrations were <20 ng/mL for 45.1% of the cohort. A total of 6.7% of women had a preterm birth. The aOR for preterm birth associated with the 1st quartile of 25-OHD concentrations compared to the 4th quartile was 1.53 (95% confidence interval (CI): 0.97-2.43). In stratified analyses, an association was observed for women with darker skin (aOR = 2.89 (95% CI: 1.02-8.18)), and no association with lighter skin. A total of 11.9% of births were SGA and there was no association overall or by skin color. Our results do not provide support for an association between maternal first trimester 25-OHD deficiency and risk of preterm or SGA birth overall; the association with preterm birth risk among women with darker skin requires further investigation.
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http://dx.doi.org/10.3390/nu11123042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6950733PMC
December 2019

PTH determination in hemodialyzed patients-A laboratory perspective.

Semin Dial 2019 11 21;32(6):490-492. Epub 2019 Oct 21.

Department of Nephrology, Dialysis and Transplantation, CHU de Liège, University of Liège, Liège, Belgium.

Parathyroid hormone (PTH) is a key player of bone remodelling in patients suffering from Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Serum PTH concentrations are thus frequently measured in CKD patients. Nevertheless, this determination is far from simple. PTH stability can be an issue and degradation of the peptide can be important if storage is not properly done. Biologically active PTH circulates together with fragments, which can be detected by some immunoassays. There is, up to now, no standardization of the assays available on the market, which can lead to some confusion when patients are followed with different methods. The upper end of the reference ranges provided by some manufacturers have not been properly established and are sometimes far too high. Finally, PTH can be oxidized in vivo and thus become inactive, while still quantified by immunoassays. In this Editorial, we will try to highlight some of these issues on PTH measurement.
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http://dx.doi.org/10.1111/sdi.12844DOI Listing
November 2019

Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE).

Neurol Neuroimmunol Neuroinflamm 2019 09 6;6(5). Epub 2019 Aug 6.

From CHU Gui de Chauliac (W.C.) and Institut de Génomique Fonctionnelle (E.T.), Université de Montpellier, France; Faculty of Economics (P.L.), UCL Mons, Louvain, Belgium; Faculty of Medicine (P.L.), the University of Melbourne, Australia; CHU Pitié Salpêtrière (C.P.-D.), Paris; GHICL St Vincent de Paul (P.H.), Lille; Merck (A.B., A.-S.J.-D., M.P.), Lyon; CHU Caremeau (E.T.), Nîmes; and CHU Necker (J.C.S.), Paris, France.

Objective: To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).

Methods: In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).

Results: The primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction ( = 0.012), less new hypointense T1-weighted lesions ( = 0.025), a lower volume of hypointense T1-weighted lesions ( = 0.031), and a lower progression of EDSS ( = 0.026). The overall rate of adverse events was well balanced between groups.

Conclusions: Although the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.

Clinicaltrialsgov Identifier: NCT01198132.

Classification Of Evidence: This study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.
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http://dx.doi.org/10.1212/NXI.0000000000000597DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6705622PMC
September 2019

Periostin and sclerostin levels in individuals with spinal cord injury and their relationship with bone mass, bone turnover, fracture and osteoporosis status.

Bone 2019 10 24;127:612-619. Epub 2019 Jul 24.

Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie, Menucourt, France.

Background: Spinal cord injury (SCI) induces an acute alteration in bone metabolism. Although the aetiology of the bone disturbances is not precisely known, immobilisation reduces mechanical loading and the morphology of osteocytes, which are the primary mechanosensors. Periostin and sclerostin are secreted mostly by osteocytes and are involved in bone's mechanical response.

Objective: The present study was conducted to determine whether individuals with SCI present alterations in serum periostin and sclerostin and to assess their relationships with bone mineral density, bone turnover markers, fracture status, time since injury, densitometric osteoporosis and paraplegic vs. tetraplegic status.

Subjects And Methods: One hundred and thirty-one individuals with SCI (96 males and 35 females; 42.8 ± 13.7 yr old) with a mean 14.2 ± 12.1 years since the time of injury were evaluated and compared with 40 able-bodied controls in a cross-sectional study. Periostin and sclerostin were assayed by ELISA from Biomedica® (Vienna, Austria), and bone turnover markers and areal bone mineral density (aBMD) were concomitantly analysed.

Results: Compared with controls, individuals with SCI presented higher periostin (p < 0.01), lower sclerostin (p < 0.001), similar markers of bone turnover levels and lower aBMD at the hip. Compared with chronic individuals, bone turnover markers, sclerostin excepted, values were higher as well as aBMD at hip in individuals with acute SCI. Moreover, the aBMD differences were more marked in tetraplegic than paraplegic individuals. Bone mineral density, fracture status, densitometric osteoporosis and paraplegia vs. tetraplegia did not seem to substantially influence the values of biological markers, sclerostin excepted.

Conclusion: This study showed for the first time that individuals with SCI presented higher periostin levels than healthy controls only during the acute phase. Conversely, sclerostin levels are lower whatever the post-injury time. Fractures and densitometric osteoporosis were not associated with differences in these two biological markers, whereas paraplegia vs. tetraplegia and fragility fracture status seemed to influence sclerostin levels only.
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http://dx.doi.org/10.1016/j.bone.2019.07.019DOI Listing
October 2019

Vitamin D Supplementation in France in patients with or at risk for osteoporosis: Recent data and new practices.

Joint Bone Spine 2020 Jan 30;87(1):25-29. Epub 2019 Apr 30.

Service de rhumatologie, CHU de Lille et EA 4490, Université de Lille, 59000 Lille, France. Electronic address:

With intermittent vitamin D supplementation, serum 25-hydroxyvitamin D (25OHD) levels may remain stable only if the dosing interval is shorter than 3 months, the ideal perhaps being about 1 month. Recent data support moderate daily vitamin D doses instead of high intermittent doses, notably in elderly patients prone to falls. The level of evidence is low, however, with no head-to-head comparisons of clinical outcomes such as fractures and falls in groups given identical dosages daily versus intermittently. A challenge to daily vitamin D supplementation in France is the absence of a suitable pharmaceutical formulation. In addition, daily dosing carries a high risk of poor adherence. Until suitable vitamin D3 formulations such as tablets or soft capsules each containing 1000 or 1500 IU become available, we suggest intermittent supplementation according to 2011 GRIO guidelines. Among the available dosages, the lowest should be preferred, with the shortest possible interval, e.g., 50,000 IU monthly rather than 100,000 every two months.
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http://dx.doi.org/10.1016/j.jbspin.2019.04.004DOI Listing
January 2020

Vitamin D, bone alkaline phosphatase and parathyroid hormone in healthy subjects and haemodialysed patients from West Africa: impact of reference ranges and parathyroid hormone generation assays on the KDIGO guidelines.

Clin Kidney J 2019 Apr 5;12(2):288-293. Epub 2018 Sep 5.

Department of Nephrology, Dialysis and Transplantation, University of Liège, CHU de Liège, Liège, Belgium.

Background: The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommend targets based on multiples of the upper limit of normal (ULN) of parathyroid hormone (PTH) concentration. However, the ULN has not always been correctly established by manufacturers. While it is known that the ULN is supposed to be higher in African Americans than in Caucasians, it is largely unknown in Africans.

Methods: We established the ULN of PTH concentration in a population of 240 healthy Ivorians using second- and third-generation PTH assays before and after supplementation with 100 000 IU of cholecalferol. We measured the levels of PTH, bone alkaline phosphatase, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in 100 haemodialysed Ivorian patients.

Results: The prevalence of vitamin D deficiency in Ivory Coast is low. The ULN obtained using the third-generation PTH assay was similar to that obtained in Caucasians but was higher when PTH was measured using the second-generation PTH assay. According to the KDIGO guidelines, ∼20% of the haemodialysed patients were below twice the ULN and 30% were above nine times the ULN. Approximately 25% of the patients were even >12 times the ULN. We observed a discrepancy in the results between the two PTH assays (14%) that was relatively more important than what we observed from previous studies in Caucasians using the same strategy.

Conclusions: We found a low prevalence of vitamin D deficiency in a tropical country like Ivory Coast. We also established the PTH reference range, which could prove useful for the follow-up of haemodialysed patients, particularly for the large number of patients suffering from secondary hyperparathyroidism who are at high risk of adverse bone events.
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http://dx.doi.org/10.1093/ckj/sfy074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6452202PMC
April 2019

Pharmacokinetics of a New Pharmaceutical Form of Vitamin D3 100,000 IU in Soft Capsule.

Nutrients 2019 Mar 26;11(3). Epub 2019 Mar 26.

EA 7517, Centre de Recherche Universitaire en Santé de l'UPJV, site Hôpital Sud, 80 054 Amiens, France.

Vitamin D deficiency is frequent in the general population and both subjects and health professionals could benefit from a broader range of vitamin D3 formulations. We conducted a single-dose, open-label, parallel-group, randomized bioequivalence study to compare a single dose of a newly developed vitamin D3 100,000 IU in a soft capsule (Group 1) with the reference drug vitamin D3 100,000 IU oral solution in ampoule (Group 2) in healthy volunteers over a four-month period. The primary endpoint was the area under the curve (AUC) of serum 25-hydroxyvitamin-D (25(OH)D) concentrations on Day 112. This study was conducted in France from February to June 2014 in 53 young adults with a mean age of 26.9 years. At baseline, low mean serum 25(OH)D levels were observed in both groups (10.6 ng/mL in Group 1 and 9.0 ng/mL in Group 2). On Day 112, the AUC of serum 25(OH)D concentration was 2499.4 ± 463.8 nmol/mL (7.8 ± 0.2 for LogAUC) for Group 1 and 2152.3 ± 479.8 nmol/mL (7.6 ± 0.2 for LogAUC) for Group 2. Bioequivalence of the two treatments was not demonstrated. Superiority of vitamin D3 100,000 IU soft capsule was observed with = 0.029 for AUC and = 0.03 for LogAUC using a non-parametric Wilcoxon test. The profile of the serum 25(OH)D concentration showed a significant difference in favor of Group 1 on Days 1, 3, 7, 14 and 90. Mean serum 25(OH)D concentrations in Group 1 were between 20 and 30 ng/mL during the four-month period and under 20 ng/mL throughout the study in Group 2, except on Day 112. Mean C for Group 1 was significantly higher ( = 0.002). Fourteen days were needed to reach T by more than half the subjects in Group 1 compared to 45 days in Group 2. Both treatments were well tolerated, with no severe or related adverse events reported. In conclusion, the pharmacokinetic profile of the new formulation of vitamin D3 100,000 IU soft capsule is superior to that of the oral solution in ampoule. The new formulation increased serum 25(OH)D levels to above 20 ng/mL and maintained levels from 20 ng/mL to 30 ng/mL for four months in late winter and spring.
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http://dx.doi.org/10.3390/nu11030703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6470992PMC
March 2019

[Vitamin D supplementation in adults: should we change our practice?]

Rev Prat 2018 Feb;68(2):127-133

Service des explorations fonctionnelles, hôpital Necker- Enfants malades, Paris, France.

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February 2018

Relationship between vitamin D status in pregnancy and the risk for preeclampsia: A nested case-control study.

Clin Nutr 2020 02 15;39(2):440-446. Epub 2019 Feb 15.

Laboratoire d'Explorations Fonctionnelles, Necker-Enfants Malades Hospital, AP-HP, Paris, France.

Background & Aims: Vitamin D is thought to be involved in the pathogenesis of preeclampsia. To evaluate the relationship between vitamin D insufficiency in the first trimester of pregnancy and preeclampsia.

Methods: Nested case-control study (FEPED study) in type 3 obstetrical units. Pregnant women from 10 to 15 WA. For each patient with preeclampsia, 4 controls were selected from the cohort and matched by parity, skin color, maternal age, season and BMI. The main outcome measure was serum 25(OH)D status in the first trimester.

Results: 83 cases of preeclampsia were matched with 319 controls. Mean 25(OH)D levels in the first trimester were 20.1 ± 9.3 ng/mL in cases and 22.3 ± 11.1 ng/mL in controls (p = 0.09). The risk for preeclampsia with 25(OH)D level ≥30 ng/mL in the first trimester was decreased, but did not achieve statistical significance (OR, 0.57; 95% CI, 0.30-1.01; p = 0.09). High 25(OH)D during the 3rd trimester was associated with a significantly decreased risk of preeclampsia (OR, 0.43; 95%CI, 0.23-0.80; p = 0.008). When women with 25(OH)D levels <30 ng/mL both in the first and 3rd trimesters ("low-low") were taken as references, OR for preeclampsia was 0.59 (95% CI, 0.31-1.14; p = 0.12) for "low-high" or "high-low" women and 0.34 (95% CI, 0.13-0.86; p = 0.02) for "high-high" women.

Conclusions: No significant association between preeclampsia and vitamin D insufficiency in the first trimester was evidenced. However, women with vitamin D sufficiency during the 3rd trimester and both in the first and 3rd trimesters had a significantly lower risk of preeclampsia.
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http://dx.doi.org/10.1016/j.clnu.2019.02.015DOI Listing
February 2020

Vitamin D status during pregnancy and in cord blood in a large prospective French cohort.

Clin Nutr 2019 10 31;38(5):2136-2144. Epub 2018 Aug 31.

Fondation PremUp, Paris, France; Department of Obstetrics and Gynecology, Antoine-Béclère Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris-Sud, Clamart, France.

Background & Aims: Vitamin D status during pregnancy and in newborns has never been studied in France. This study aims at determining the vitamin D status during the first and third trimesters of pregnancy (T1, T3) and in cord blood (CB) in the middle-north of France.

Methods: We conducted a prospective cohort study in five French centers (latitude 47.22 to 48.86°N). Serum 25(OH)-vitamin D (25(OH)D) concentrations were measured using a radioimmunoassay during T1, T3 and in CB. According to the French guidelines, pregnant women received cholecalciferol, 100,000 IU, in the seventh month.

Results: Between April 2012 and July 2014, 2832 women were included, of whom 2803 were analyzed (mean ± SD age: 31.5 ± 5.0 years; phototypes 5-6: 21.8%). Three and 88.6% of participants received supplementation during the month before inclusion and in the seventh month, respectively. At T1, T3, and CB, mean 25(OH)D concentrations were 21.9 ± 10.4, 31.8 ± 11.5, and 17.0 ± 7.2 ng/mL, respectively, and 25(OH)D was <20 ng/mL in 46.5%, 14.0%, and 68.5%, respectively. At T1, body mass index ≥25 kg/m, dark phototypes, sampling outside summer, and no supplementation before inclusion were independently associated with vitamin D insufficiency (25(OH)D < 20 ng/mL). Women who received cholecalciferol supplementation in month 7 had higher 25(OH)D at T3 than non-supplemented women (32.5 ± 11.4 versus 25.8 ± 11.4 ng/mL, p = <0.001) and marginally higher 25(OH)D in CB (17.2 ± 7.2 versus 15.5 ± 7.1 ng/mL, p = 0.004).

Conclusions: Despite the recommended supplementation, vitamin D insufficiency is frequent during pregnancy and in newborns in France.
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http://dx.doi.org/10.1016/j.clnu.2018.08.035DOI Listing
October 2019

Moving from the second to the third generation Roche PTH assays: what are the consequences for clinical practice?

Clin Chem Lab Med 2018 12;57(2):244-249

Laboratoire de Biochimie et Hormonologie, CHU Montpellier, University Montpellier 1, 371 Avenue Doyen Gaston Giraud, Montpellier 34295, France.

Background The determination of parathyroid hormone (PTH) is essential for exploring phosphocalcic disorders especially in patients with renal failure. At present, second or third generation PTH assays are available on the market from Roche Diagnostics as well as from others companies but the lack of standardization has complicated the interpretation. Methods We wanted to assess the clinical impact by measuring the PTH levels with the two generations concomitantly on different groups of populations including 46 healthy, 103 pre-dialyzed and 73 hemodialyzed (HD) patients. Results In healthy subjects, the PTH concentrations were not different whatever the generation used, whereas beyond 200 pg/mL, we reported an overestimation of the second generation PTH. In patients with chronic kidney disease (CKD) stage 3-5 the observed differences between the two generations increase with increasing PTH levels and decreasing glomerular filtration rate (GFR). Classification according to the kidney disease: improving global outcomes (KDIGO) revealed a high percentage of discordant results between the two generations (κ coefficient <0.20). These discrepancies are clinically relevant as PTH levels remain the cornerstone for diagnosis and treatment of the CKD-mineral and bone disorder (CKD-MBD). Conclusions The introduction of a new PTH assay generation in clinical practice should be carried out with caution.
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http://dx.doi.org/10.1515/cclm-2018-0300DOI Listing
December 2018

Vitamin D and its metabolites: from now and beyond.

EJIFCC 2018 Jul 11;29(2):105-110. Epub 2018 Jul 11.

Laboratoire d'Explorations fonctionnelles, Hôpital Necker-Enfants malades, Paris, France.

Total 25-hydroxyvitamin D is currently considered as the most representative metabolite of vitamin D status. There are a multitude of challenges that still deserve to be addressed and despite recent technological advances its determination remains complicated. This current review gives an abbreviated overview of the phases of development that vitamin D metabolite determination has gone through and discusses the difficulties that still require resolving. Furthermore, given the different platforms and methodologies available, the critical issue of standardization and all efforts made as far towards its realization have been discussed. And last but not least, the concepts of 'free' and 'bioavailable' vitamin D along with the 'Vitamin D Metabolism Ratio' have been discussed.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053816PMC
July 2018

Comparison of two bone markers with growth evolution in 74 girls with central precocious puberty.

BMC Pediatr 2018 07 9;18(1):224. Epub 2018 Jul 9.

Fondation Ophtalmologique Adolphe de Rothschild and Université Paris Descartes, 75940, Paris, France.

Background: The bone markers bone alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen crosslinks (CTX) are correlated with growth rate during normal puberty. The objective of this study was to evaluate the relationship between the serum concentrations of BAP and CTX and growth evolution in girls with idiopathic central precocious puberty (CPP) to help predict adult height.

Methods: A retrospective single-center study was conducted in 74 girls with CPP for whom a serum sample at initial evaluation was available to retrospectively measure BAP and CTX concentrations; 66.2% of them were untreated.

Results: The serum BAP concentrations showed significant positive correlations with height in standard deviations (SDS) at the initial evaluation (n = 62; r = 0.31; p = 0.015) and with the difference between bone and chronological ages (n = 61; r = 0.39; p = 0.002). BAP was also positively correlated with adult height as measured in both cm and SDS in untreated patients (n = 19; r = 0.58; p = 0.009). The serum CTX concentrations showed significant positive correlations with growth rate the year before the initial evaluation as measured in both cm and SDS (n = 65; r = 0.34; p = 0.006).

Conclusions: This study revealed significant correlations of serum BAP and CTX concentrations with growth evolution in girls with CPP. The high positive correlation between serum BAP and adult height in untreated girls suggests that BAP can possibly be used to optimize models of adult height prediction in girls with CPP.
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http://dx.doi.org/10.1186/s12887-018-1194-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6038288PMC
July 2018

Severe secondary hyperparathyroidism in patients on haemodialysis is associated with a high initial serum parathyroid hormone and beta-CrossLaps level: Results from an incident cohort.

PLoS One 2018 18;13(6):e0199140. Epub 2018 Jun 18.

NEPHROCARE Tassin-Charcot, Haemodialysis, Sainte Foy-les-Lyon,France.

Background: Secondary hyperparathyroidism (SHPT) is a frequent complication of renal disease and most commonly occurs in patients on haemodialysis (HD) with metabolic, vascular, endocrine, and bone complications. The aim of this study was to analyze the evolution of mineral metabolism parameters during the first 36 months of HD treatment and identify the initial factors associated with severe SHPT.

Methods: Serum parathyroid hormone (PTH), calcium and phosphate levels were measured monthly; bone-specific alkaline phosphatase (b-ALP) and beta-CrossLaps (CTX) were measured biannually. Severe SHPT was defined as the need for cinacalcet treatment. Patients with less than 24 months of follow-up were excluded.

Results: One hundred thirty-three incident HD patients were included. Baseline mean PTH was 275 ± 210 pg/mL. After an initial drop at the third month (172 ± 133 pg/mL), the serum PTH level progressively increased to the maximum at 36 months (367 ± 254 pg/mL). This initial drop was associated with the initial correction of both hypocalcaemia and hyperphosphataemia. Serum CTX and b-ALP revealed no significant changes over time. Severe SHPT was observed in 18% of patients and was associated with higher mean calcaemia and phosphataemia. In logistic regression, the initial factors associated with the risk of severe SHPT were: female sex, higher baseline PTH and CTX values. A receiver operation characteristic curve analysis identified a cut-off value of >374 pg/mL for baseline PTH and >1.2 μg/L for CTX for increased risk of developing severe SHPT. The relative risk of developing severe SHPT was 3.7 (1.8-7.5, p = 0.002) for high baseline CTX, 4.9 (2.4-9.7, p = 0.001) for high baseline PTH, and 7.7 (3.6-16, p< 0.0001) when both criteria were present.

Conclusion: After an initial drop, a progressive increase in the serum PTH level during the first 3 years of HD treatment was observed despite aggressive therapy. High baseline levels of PTH and CTX increased the risk of developing severe SHPT.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0199140PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6005469PMC
December 2018

A Randomized Study to Compare a Monthly to a Daily Administration of Vitamin D₃ Supplementation.

Nutrients 2018 May 23;10(6). Epub 2018 May 23.

Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium.

We aimed to determine whether a cumulative dose of vitamin D₃ produces the same effects on the serum concentration of 25(OH)D₃ if it is given daily or monthly. This is a monocentric, two-armed, randomized, interventional, open, and parallel study conducted from November 2016 to March 2017 in Belgium. We randomized 60 subjects with vitamin D deficiency to receive 2000 IU vitamin D₃ daily or 50,000 IU monthly. The same cumulative dose of vitamin D₃ was given to each treatment group (150,000 IU). The 25(OH)D₃ serum concentrations from baseline to day 75 were 14.3 ± 3.7 to 27.8 ± 3.9 ng/mL in the monthly group and 14.1 ± 3.4 to 28.8 ± 5.4 ng/mL in the daily group. The mean change versus the baseline level was significantly different between the groups at day 2, 4, 7, and 14 and no longer different from day 25. One day after the intake of vitamin D₃, as expected, serum 25(OH)D₃ and 1,25(OH)₂D₃ increased significantly in the monthly group, whereas they did not change significantly in the daily group. The median time to reach the 20 ng/mL target concentration was significantly different in the two groups, in favor of the monthly regimen (1 day versus 14 days; = 0.02). In conclusion, a monthly administration of 50,000 IU vitamin D₃ provides an effective tool for a rapid normalization of 25(OH)D₃ in deficient subjects. A daily administration of the same cumulative dose is similarly effective but takes two weeks longer to reach the desirable level of 20 ng/mL.
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http://dx.doi.org/10.3390/nu10060659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6024703PMC
May 2018

Do dietary calcium and vitamin D matter in men with prostate cancer?

Nat Rev Urol 2018 07;15(7):453-461

Inserm Unit 1151, Institut Necker-Enfants Malades (INEM), Université Paris Descartes, Paris, France.

Active surveillance (AS) is an attractive alternative to immediate treatment for men with low-risk prostate cancer. Thus, the identification of environmental factors that promote the progression of indolent disease towards aggressive stages is critical to optimize clinical management. Epidemiological studies suggest that calcium-rich diets contribute to an increased risk of developing prostate cancer and that vitamin D reduces this risk. However, the potential effect of these nutrients on the progression of early-stage prostate tumours is uncertain, as studies in this setting are scarce and have not provided unambiguous conclusions. By contrast, the results of a preclinical study from our own group demonstrate that a diet high in calcium dose-dependently accelerated the progression of early-stage prostate tumours and that dietary vitamin D prevented this effect. The extent to which the conclusions of preclinical and epidemiological studies support a role for calcium and vitamin D and the relevance of monitoring and adjustment of calcium and/or vitamin D intake in patients on AS require further investigation.
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http://dx.doi.org/10.1038/s41585-018-0015-zDOI Listing
July 2018
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