Long-term effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme (a double-blind placebo-controlled study) – rationale for the study design

BMC Pediatrics

Study Protocol

Piotr Socha¹  Agnieszka Szlagatys-Sidorkiewicz²  Agnieszka Jankowska²  Michał Brzeziński³  Magdalena Słomińska-Frączek⁴  Paulina Metelska⁵ 

[1] Department of Gastroenterology, Hepatology and Feeding Disorders, The Children’s Memorial Health Institute, Dzieci Polskich 20, 00-999, Warsaw, Poland;Department of Paediatrics, Gastroenterology, Hepatology and Nutrition, Medical University of Gdańsk, ul. Nowe Ogrody, 1-6 80-803, Gdańsk, Poland;Department of Public Health and Social Medicine, Medical University of Gdansk, Zwycięstwa 42a, 80-210, Gdansk, Poland;Pomeranian Medical Centre, Nowe Ogrody 1-6, 80-803, Gdansk, Poland;“6-10-14 for Health” University Clinical Centre, Dębinki 7, 80-210, Gdansk, Poland;

关键词: Vitamin D;    Obesity;    Weight loss;    Body composition;   

DOI  :  10.1186/s12887-017-0851-7

 received in 2017-01-10, accepted in 2017-03-29,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundObesity is associated not only with an array of metabolic disorders (e.g. insulin resistance, hiperinsulinemia, impaired tolerance of glucose, lipid disorders) but also skeletal and joint abnormalities. Recently, a pleiotropic role of vitamin D has been emphasized. Obese children frequently present with vitamin D deficiency, and greater fat mass is associated with lower serum concentration of this vitamin. Although some evidence suggests that weight loss may affect vitamin D status, this issue has not been studied extensively thus far. The aim of a double-blind placebo-controlled study is to assess long-term health effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme.MethodsA randomized double-blind, placebo-controlled trial analysing the effects of vitamin D3 supplementation in overweight or obese vitamin D deficient (<30 ng/ml) children participating in an integrated weight-loss programme. Children are randomized to receive either vitamin D (1200 IU) or placebo for 26 weeks. Primary endpoints include changes in BMI (body mass index), body composition and bone mineral density at the end of the study period, and secondary endpoints – the changes in laboratory parameter reflecting liver and kidney function (transaminases, creatinine) and glucose homeostasis (glucose and insulin levels during oral glucose tolerance test).DiscussionThe effects of vitamin D supplementation in obese individuals, especially children, subjected to a weight-loss program are still poorly understood. Considering physiological processes associated with puberty and adolescent growth, we speculate that supplementation may enhance weight reduction and prevent bone loss in obese children deficient in this vitamin.Trial registrationNCT 02828228; Trial registration date: 8 Jun 2016; Registered in: ClinicalTrials.gov. The trial was registered retrospectively.

【 授权许可】

CC BY   
© The Author(s). 2017