Publications by authors named "Marta García Solano"

14 Publications

  • Page 1 of 1

Methodology and implementation of the WHO European Childhood Obesity Surveillance Initiative (COSI).

Obes Rev 2021 Nov 4;22 Suppl 6:e13215. Epub 2021 Nov 4.

Department of Epidemiology and Public Health Sciensano, Brussels, Belgium.

Establishment of the WHO European Childhood Obesity Surveillance Initiative (COSI) has resulted in a surveillance system which provides regular, reliable, timely, and accurate data on children's weight status-through standardized measurement of bodyweight and height-in the WHO European Region. Additional data on dietary intake, physical activity, sedentary behavior, family background, and school environments are collected in several countries. In total, 45 countries in the European Region have participated in COSI. The first five data collection rounds, between 2007 and 2021, yielded measured anthropometric data on over 1.3 million children. In COSI, data are collected according to a common protocol, using standardized instruments and procedures. The systematic collection and analysis of these data enables intercountry comparisons and reveals differences in the prevalence of childhood thinness, overweight, normal weight, and obesity between and within populations. Furthermore, it facilitates investigation of the relationship between overweight, obesity, and potential risk or protective factors and improves the understanding of the development of overweight and obesity in European primary-school children in order to support appropriate and effective policy responses.
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http://dx.doi.org/10.1111/obr.13215DOI Listing
November 2021

Childhood overweight and obesity in Europe: Changes from 2007 to 2017.

Obes Rev 2021 Nov 10;22 Suppl 6:e13226. Epub 2021 Aug 10.

World Health Organization (WHO) European Office for the Prevention and Control of Noncommunicable Diseases, Division of Country Health Programmes, WHO Regional Office for Europe, Moscow, Russian Federation.

The Childhood Obesity Surveillance Initiative (COSI) routinely measures height and weight of primary school children aged 6-9 years and calculates overweight and obesity prevalence within the World Health Organization (WHO) European Region using a standard methodology. This study examines the trends in the prevalence of overweight and obesity from the first round of COSI carried out in 2007/2008 to the latest of 2015/2017 in 11 European countries in which data were collected for at least three rounds. In total 303,155 children were measured. In general, the prevalence of overweight and obesity among boys and girls decreased in countries with high prevalence (Southern Europe) and remained stable or slightly increased in Northern European and Eastern European countries included in the analysis. Among boys, the highest decrease in overweight (including obesity) was observed in Portugal (from 40.5% in 2007/2008 to 28.4 in 2015/2017) and in Greece for obesity (from 30.5% in 2009/2010 to 21.7% in 2015/2017). Lithuania recorded the strongest increase in the proportion of boys with overweight (from 24.8% to 28.5%) and obesity (from 9.4% to 12.2%). The trends were similar for boys and girls in most countries. Several countries in Europe have successfully implemented policies and interventions to counteract the increase of overweight and obesity, but there is still much to be done.
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http://dx.doi.org/10.1111/obr.13226DOI Listing
November 2021

[Weight status in the 6- to 9-year-old school population in Spain: results of the ALADINO 2019 Study].

Nutr Hosp 2021 Oct;38(5):943-953

Vocalía Asesora para la Estrategia NAOS. Agencia Española de Seguridad Alimentaria y Nutrición. Ministerio de Consumo.

Introduction: Introduction: childhood obesity is a public health problem whose prevalence has grown steadily in recent decades. Objective: to describe the weight status of schoolchildren aged 6 to 9 years in Spain in 2019, and their associated factors. Methods: ALADINO is a cross-sectional study in schoolchildren aged 6 to 9 years, representative of the Spanish population, and aligned with the Child Obesity Surveillance Initative of the WHO Regional Office for Europe. Participants' weight, height, and abdominal circumference were measured, defining weight status according to different standards (WHO, IOTF, and Orbegozo). A questionnaire on lifestyle and socio-demographic characteristics was administered to parents. Results: a total of 16,665 schoolchildren from 276 schools were measured. Excess weight was observed in 40.6 %: 23.3 % overweight and 17.3 % obesity, with obesity being more prevalent in boys and overweight in girls, both increasing with age. The prevalence of abdominal obesity was 22.6 %. Excess weight decreased by 3.9 percentage points since 2011, mainly due to overweight in boys. Obesity remained stable. Excess weight was more prevalent in schoolchildren with less healthy eating and physical activity habits, and in families with a lower socioeconomic status. Conclusions: the prevalence of excess weight is high, although it has declined since 2011 and remains stable since 2015 among schoolchildren aged 6-9 years in Spain, this reduction being mainly due to a decrease in overweight in children. It is necessary to continue promoting healthy habits from the earliest stages of life, thus reducing health inequalities.
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http://dx.doi.org/10.20960/nh.03618DOI Listing
October 2021

Thinness, overweight, and obesity in 6- to 9-year-old children from 36 countries: The World Health Organization European Childhood Obesity Surveillance Initiative-COSI 2015-2017.

Obes Rev 2021 Nov 7;22 Suppl 6:e13214. Epub 2021 Jul 7.

Center for Health Ecology, Institute of Public Health, Podgorica, Montenegro.

In 2015-2017, the fourth round of the World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) was conducted in 36 countries. National representative samples of children aged 6-9 (203,323) were measured by trained staff, with similar equipment and using a standardized protocol. This paper assesses the children's body weight status and compares the burden of childhood overweight, obesity, and thinness in Northern, Eastern, and Southern Europe and Central Asia. The results show great geographic variability in height, weight, and body mass index. On average, the children of Northern Europe were the tallest, those of Southern Europe the heaviest, and the children living in Central Asia the lightest and the shortest. Overall, 28.7% of boys and 26.5% of girls were overweight (including obesity) and 2.5% and 1.9%, respectively, were thin according to the WHO definitions. The prevalence of obesity varied from 1.8% of boys and 1.1% of girls in Tajikistan to 21.5% and 19.2%, respectively, in Cyprus, and tended to be higher for boys than for girls. Levels of thinness, stunting, and underweight were relatively low, except in Eastern Europe (for thinness) and in Central Asia. Despite the efforts to halt it, unhealthy weight status is still an important problem in the WHO European Region.
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http://dx.doi.org/10.1111/obr.13214DOI Listing
November 2021

Socioeconomic disparities in physical activity, sedentary behavior and sleep patterns among 6- to 9-year-old children from 24 countries in the WHO European region.

Obes Rev 2021 Nov 7;22 Suppl 6:e13209. Epub 2021 Jul 7.

Division of Noncommunicable Diseases and Promoting Health through the Life-Course, WHO Country Office for Tajikistan, Dushanbe, Tajikistan.

Physical activity, sedentary behavior, and sleep are important predictors of children's health. This paper aimed to investigate socioeconomic disparities in physical activity, sedentary behavior, and sleep across the WHO European region. This cross-sectional study used data on 124,700 children aged 6 to 9 years from 24 countries participating in the WHO European Childhood Obesity Surveillance Initiative between 2015 and 2017. Socioeconomic status (SES) was measured through parental education, parental employment status, and family perceived wealth. Overall, results showed different patterns in socioeconomic disparities in children's movement behaviors across countries. In general, high SES children were more likely to use motorized transportation. Low SES children were less likely to participate in sports clubs and more likely to have more than 2 h/day of screen time. Children with low parental education had a 2.24 [95% CI 1.94-2.58] times higher risk of practising sports for less than 2 h/week. In the pooled analysis, SES was not significantly related to active play. The relationship between SES and sleep varied by the SES indicator used. Importantly, results showed that low SES is not always associated with a higher prevalence of "less healthy" behaviors. There is a great diversity in SES patterns across countries which supports the need for country-specific, targeted public health interventions.
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http://dx.doi.org/10.1111/obr.13209DOI Listing
November 2021

Socioeconomic differences in food habits among 6- to 9-year-old children from 23 countries-WHO European Childhood Obesity Surveillance Initiative (COSI 2015/2017).

Obes Rev 2021 Nov 7;22 Suppl 6:e13211. Epub 2021 Jul 7.

World Health Organization (WHO) European Office for the Prevention and Control of Noncommunicable Diseases, Division of Country Health Programmes, WHO Regional Office for Europe, Moscow, Russian Federation.

Background: Socioeconomic differences in children's food habits are a key public health concern. In order to inform policy makers, cross-country surveillance studies of dietary patterns across socioeconomic groups are required. The purpose of this study was to examine associations between socioeconomic status (SES) and children's food habits.

Methods: The study was based on nationally representative data from children aged 6-9 years (n = 129,164) in 23 countries in the World Health Organization (WHO) European Region. Multivariate multilevel analyses were used to explore associations between children's food habits (consumption of fruit, vegetables, and sugar-containing soft drinks) and parental education, perceived family wealth and parental employment status.

Results: Overall, the present study suggests that unhealthy food habits are associated with lower SES, particularly as assessed by parental education and family perceived wealth, but not parental employment status. We found cross-national and regional variation in associations between SES and food habits and differences in the extent to which the respective indicators of SES were related to children's diet.

Conclusion: Socioeconomic differences in children's food habits exist in the majority of European and Asian countries examined in this study. The results are of relevance when addressing strategies, policy actions, and interventions targeting social inequalities in children's diets.
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http://dx.doi.org/10.1111/obr.13211DOI Listing
November 2021

Socioeconomic inequalities in overweight and obesity among 6- to 9-year-old children in 24 countries from the World Health Organization European region.

Obes Rev 2021 Nov 28;22 Suppl 6:e13213. Epub 2021 Jun 28.

Center for Health Ecology, Institute of Public Health, Podgorica, Montenegro.

Childhood overweight and obesity have significant short- and long-term negative impacts on children's health and well-being. These challenges are unequally distributed according to socioeconomic status (SES); however, previous studies have often lacked standardized and objectively measured data across national contexts to assess these differences. This study provides a cross-sectional picture of the association between SES and childhood overweight and obesity, based on data from 123,487 children aged 6-9 years in 24 countries in the World Health Organization (WHO) European region. Overall, associations were found between overweight/obesity and the three SES indicators used (parental education, parental employment status, and family-perceived wealth). Our results showed an inverse relationship between the prevalence of childhood overweight/obesity and parental education in high-income countries, whereas the opposite relationship was observed in most of the middle-income countries. The same applied to family-perceived wealth, although parental employment status appeared to be less associated with overweight and obesity or not associated at all. This paper highlights the need for close attention to context when designing interventions, as the association between SES and childhood overweight and obesity varies by country economic development. Population-based interventions have an important role to play, but policies that target specific SES groups are also needed to address inequalities.
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http://dx.doi.org/10.1111/obr.13213DOI Listing
November 2021

Weight status in the 6 to 9 year-old school population in Spain: Results of the ALADINO 2015 study.

An Pediatr (Engl Ed) 2021 Jun 14;94(6):366-376. Epub 2021 May 14.

Departamento de Salud Pública y Psiquiatría, Facultad de Medicina, Universidad de Málaga, Málaga, Spain.

Introduction: Overweight and obesity in childhood and adolescence has grown alarmingly in the last twenty years or so in many countries of Europe, including Spain. This study presents the prevalences of overweight and obesity in 6-9 year-old schoolchildren in 2015, and their associated characteristics.

Methodology: ALADINO (Its initials in Spanish for Diet, physical activity, child development and obesity) is a cross-sectional study of a representative sample of 6-9 year-old schoolchildren in Spain, in line with the Childhood Obesity Surveillance Initiative (COSI) of the World Health Organisation (WHO). The height and weight of the participants, defining the weight status according to WHO standards, and a questionnaire was given to the parents on lifestyle and sociodemographic characteristics.

Results: Anthropometric measurements were taken on 10,899 schoolchildren for 168 primary education centres. Excess weight was observed in 41.3% (95% CI: 40.0-42.6), overweight in 23.2% (95% CI: 22.1-24.3) and obesity in 18.1% (95% CI: 17.2-19.1), with obesity being more prevalent in boys, overweight in girls. The prevalence of abdominal obesity was 23.2% (95% CI: 21.8-24.6). The prevalence of overweight and obesity increased with age. Excess weight decreased by 3.2% compared to 2011, mainly due to the decrease in overweight in boys, while that of obesity remained stable. Excess weight was more prevalent in schoolchildren from families with a lower socioeconomic level.

Conclusions: The prevalence of excess weight in 6-9 year-old schoolchildren in Spain has decreased by 3.2% since 2011, due to the decrease in overweight, whilst obesity remained stable. Action must be taken in the obesogenic environment, by promoting healthy eating habits and physical activity, bearing in mind the inequalities in health.
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http://dx.doi.org/10.1016/j.anpede.2020.05.010DOI Listing
June 2021

Physical Activity, Screen Time, and Sleep Duration of Children Aged 6-9 Years in 25 Countries: An Analysis within the WHO European Childhood Obesity Surveillance Initiative (COSI) 2015-2017.

Obes Facts 2021 22;14(1):32-44. Epub 2020 Dec 22.

National Institute of Health Dr Ricardo Jorge I.P., Lisbon, Portugal.

Background: Children are becoming less physically active as opportunities for safe active play, recreational activities, and active transport decrease. At the same time, sedentary screen-based activities both during school and leisure time are increasing.

Objectives: This study aimed to evaluate physical activity (PA), screen time, and sleep duration of girls and boys aged 6-9 years in Europe using data from the WHO European Childhood Obesity Surveillance Initiative (COSI).

Method: The fourth COSI data collection round was conducted in 2015-2017, using a standardized protocol that included a family form completed by parents with specific questions about their children's PA, screen time, and sleep duration.

Results: Nationally representative data from 25 countries was included and information on the PA behaviour, screen time, and sleep duration of 150,651 children was analysed. Pooled analysis showed that: 79.4% were actively playing for >1 h each day, 53.9% were not members of a sport or dancing club, 50.0% walked or cycled to school each day, 60.2% engaged in screen time for <2 h/day, and 84.9% slept for 9-11 h/night. Country-specific analyses of these behaviours showed pronounced differences, with national prevalences in the range of 61.7-98.3% actively playing for >1 h/day, 8.2-85.6% were not members of a sport or dancing club, 17.7-94.0% walked or cycled to school each day, 32.3-80.0% engaged in screen time for <2 h/day, and 50.0-95.8% slept for 9-11 h/night.

Conclusions: The prevalence of engagement in PA and the achievement of healthy screen time and sleep duration are heterogenous across the region. Policymakers and other stakeholders, including school administrators and parents, should increase opportunities for young people to participate in daily PA as well as explore solutions to address excessive screen time and short sleep duration to improve the overall physical and mental health and well-being of children.
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http://dx.doi.org/10.1159/000511263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983588PMC
July 2021

A Snapshot of European Children's Eating Habits: Results from the Fourth Round of the WHO European Childhood Obesity Surveillance Initiative (COSI).

Nutrients 2020 Aug 17;12(8). Epub 2020 Aug 17.

Department for Organization of Health Services to Children, Mothers, Adolescents and Family Planning, Ministry of Health and Social Protection of Population, 734025 Dushanbe, Tajikistan.

Consuming a healthy diet in childhood helps to protect against malnutrition and noncommunicable diseases (NCDs). This cross-sectional study described the diets of 132,489 children aged six to nine years from 23 countries participating in round four (2015-2017) of the WHO European Childhood Obesity Surveillance Initiative (COSI). Children's parents or caregivers were asked to complete a questionnaire that contained indicators of energy-balance-related behaviors (including diet). For each country, we calculated the percentage of children who consumed breakfast, fruit, vegetables, sweet snacks or soft drinks "every day", "most days (four to six days per week)", "some days (one to three days per week)", or "never or less than once a week". We reported these results stratified by country, sex, and region. On a daily basis, most children (78.5%) consumed breakfast, fewer than half (42.5%) consumed fruit, fewer than a quarter (22.6%) consumed fresh vegetables, and around one in ten consumed sweet snacks or soft drinks (10.3% and 9.4%, respectively); however, there were large between-country differences. This paper highlights an urgent need to create healthier food and drink environments, reinforce health systems to promote healthy diets, and continue to support child nutrition and obesity surveillance.
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http://dx.doi.org/10.3390/nu12082481DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7468747PMC
August 2020

Sugar Content in Processed Foods in Spain and a Comparison of Mandatory Nutrition Labelling and Laboratory Values.

Nutrients 2020 Apr 13;12(4). Epub 2020 Apr 13.

Spanish Food Safety and Nutrition Agency, Alcala, 56, 28014Madrid, Spain.

To reduce the sugar content of processed foods through reformulation, the first step is to determine the content of the largest sources of sugars in each country's diet. The aim of this work was to describe the sugar content in the most commonly consumed processed foods in Spain and to compare that sugar's labelling and laboratory analysis values (LVs and AVs, respectively) to confirm its adequacy. A sample of the 1173 most commonly consumed processed foods in Spain (28 groups; 77 subcategories) was collected. For each product, the total sugar content was compared according to its AV and LV. The median (25 -75 percentiles, interquartile range) sugar content by group was calculated for the total sample, and the groups were classified as "high sugar content" when this value was above 22.5 g/100g of product. The adequacy of the LV, according to the European Union (EU) tolerance requirements, was then evaluated, and each subcategory median was compared with the AV to determine its appropriateness via a median test for independent samples ( < 0.05). In total, 10 out of 28 groups presented high sugar content. Moreover, 98.4% of the products met the EU tolerance ranges. Finally, only one subcategory ("cured ham") presented significant differences between the AV and LV median values (0.4 g vs. 0.1 g sugar/100g, < 0.05). The groups of food products whose sugar content reduction could have the greatest impact on public health were identified. In addition, our study showed the high adequacy of LV with the EU labeling tolerance requirements, as well as the LV's appropriateness as a tool to implement actions aimed at reducing sugar consumption.
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http://dx.doi.org/10.3390/nu12041078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7231220PMC
April 2020

Association between Characteristics at Birth, Breastfeeding and Obesity in 22 Countries: The WHO European Childhood Obesity Surveillance Initiative - COSI 2015/2017.

Obes Facts 2019 26;12(2):226-243. Epub 2019 Apr 26.

NCD Office, WHO European Office for Prevention and Control of Noncommunicable Diseases, Moscow, Russian Federation.

Background: In Europe, although the prevalence of childhood obesity seems to be plateauing in some countries, progress on tackling this important public health issue remains slow and inconsistent. Breastfeeding has been described as a protective factor, and the more exclusively and the longer children are breastfed, the greater their protection from obesity. Birth weight has been shown to have a positive association with later risk for obesity.

Objectives: It was the aim of this paper to investigate the association of early-life factors, namely breastfeeding, exclusive breastfeeding and birth weight, with obesity among children.

Method: Data from 22 participating countries in the WHO European COSI study (round 4: 2015/2017) were collected using cross-sectional, nationally representative samples of 6- to 9-year-olds (n = 100,583). The children's standardized weight and height measurements followed a common WHO protocol. Information on the children's birth weight and breastfeeding practice and duration was collected through a family record form. A multivariate multilevel logistic regression analysis regarding breastfeeding practice (both general and exclusive) and characteristics at birth was performed.

Results: The highest prevalence rates of obesity were observed in Spain (17.7%), Malta (17.2%) and Italy (16.8%). A wide between-country disparity in breastfeeding prevalence was found. Tajikistan had the highest percentage of children that were breastfed for ≥6 months (94.4%) and exclusively breastfed for ≥6 months (73.3%). In France, Ireland and Malta, only around 1 in 4 children was breastfed for ≥6 months. Italy and Malta showed the highest prevalence of obesity among children who have never been breastfed (21.2%), followed by Spain (21.0%). The pooled analysis showed that, compared to children who were breastfed for at least 6 months, the odds of being obese were higher among children never breastfed or breastfed for a shorter period, both in case of general (adjusted odds ratio [adjOR] [95% CI] 1.22 [1.16-1.28] and 1.12 [1.07-1.16], respectively) and exclusive breastfeeding (adjOR [95% CI] 1.25 [1.17-1.36] and 1.05 [0.99-1.12], respectively). Higher birth weight was associated with a higher risk of being overweight, which was reported in 11 out of the 22 countries. Bulgaria, Croatia, France, Italy, Poland and Romania showed that children who were preterm at birth had higher odds of being obese, compared to children who were full-term babies.

Conclusion: The present work confirms the beneficial effect of breastfeeding against obesity, which was highly increased if children had never been breastfed or had been breastfed for a shorter period. Nevertheless, adoption of exclusive breastfeeding is below global recommendations and far from the target endorsed by the WHO Member States at the World Health Assembly Global Targets for Nutrition of increasing the prevalence of exclusive breastfeeding in the first 6 months up to at least 50% by 2025.
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http://dx.doi.org/10.1159/000500425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547266PMC
February 2020

[To promote knowledge on patient safety: the case of the Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library)].

Rev Esp Salud Publica 2019 Mar 12;93. Epub 2019 Mar 12.

Servicio Medicina Preventiva. Hospital Universitario Ramón y Cajal. Consejería de Sanidad. Comunidad de Madrid. España.

Objective: Within the framework of the Patient Safety Strategy 2015-2020, the Regional Ministry of Health of the Community of Madrid developed two lines of action to consolidate the Patient Safety Culture through the dissemination of scientific knowledge in Patient Safety. The main objective was to identify, disseminate and improve access to relevant information on patient safety for patient-citizens, professionals and the organization itself through a pool of resources accessible on the Internet and intranet.

Methods: After an analysis of the tools and communication channels available to disseminate knowledge in patient safety, the references of interest were selected by a group of experts, a consultation tool was developed in a navigable format on the internet and various dissemination actions were carried out to make it known.

Results: The Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library) was developed, accessible for navigation on the web of the Community of Madrid and as a download document, with 154 references, structured in 4 areas: General resources (74 references), Resources by thematic area (51 references), Videos and multimedia (12 references) and Organizations and websites of interest (17 references).

Conclusions: The Biblioteca Breve de Seguridad del Paciente (Brief Patient Safety Library) can help to promote the safety culture in health centers and to achieve greater citizen involvement in their safety, by providing reliable information on this crosscutting dimension of clinical practice.
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March 2019

Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12).

BMC Public Health 2012 May 31;12:394. Epub 2012 May 31.

Unidad de Apoyo a la Investigación, Gerencia Atención Primaria, Servicio Madrileño de Salud, Calle Espronceda 24, Madrid 28003, Spain.

Background: The oral administration of vitamin B12 offers a potentially simpler and cheaper alternative to parenteral administration, but its effectiveness has not been definitively demonstrated. The following protocol was designed to compare the effectiveness of orally and intramuscularly administered vitamin B12 in the treatment of patients ≥65 years of age with vitamin B12 deficiency.

Methods/design: The proposed study involves a controlled, randomised, multicentre, parallel, non-inferiority clinical trial lasting one year, involving 23 primary healthcare centres in the Madrid region (Spain), and patients ≥65 years of age. The minimum number of patients required for the study was calculated as 320 (160 in each arm). Bearing in mind an estimated 8-10% prevalence of vitamin B12 deficiency among the population of this age group, an initial sample of 3556 patients will need to be recruited. Eligible patients will be randomly assigned to one of the two treatment arms. In the intramuscular treatment arm, vitamin B12 will be administered as follows: 1 mg on alternate days in weeks 1 and 2, 1 mg/week in weeks 3-8,and 1 mg/month in weeks 9-52. In the oral arm, the vitamin will be administered as: 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences. All statistical tests will be performed with intention to treat and per protocol. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.

Discussion: The results of this study should help establish, taking quality of life into account, whether the oral administration of vitamin B12 is an effective alternative to its intramuscular administration. If this administration route is effective, it should provide a cheaper means of treating vitamin B12 deficiency while inducing fewer adverse effects. Having such an alternative would also allow patient preferences to be taken into consideration at the time of prescribing treatment.

Trial Registration: This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.
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http://dx.doi.org/10.1186/1471-2458-12-394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3403849PMC
May 2012
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