Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents — Obevidos  

Obesity, Childhood Clinical Trial

Official title: Treatment of Vitamin D Deficit in Obese Children and Adolescents: a Multi-centre Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level. A French-Swiss Collaboration

Status Not yet recruiting

Clinical Trial Summary

Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed, according to INPES in 2006, overweight and obesity were affecting 18 % of French children between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese children are likely to develop chronic disease, starting at paediatric age, as cardiovascular or bone diseases, or type 2 diabetes.

Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial hypertension and type 2 diabetes development.

Obesity, in adults like in children, is associated with vitamin D deficiency. Common explanations for this low serum concentration of 25(OH)D in obese are the sequestration and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore, obese population is at higher risk of developing cardiovascular and metabolic complications.

The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit is difficult to cure with classical loading doses. It seems that these patients need higher dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration (daily vs monthly) was never evaluated.

Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular system, adipose tissue) and in light of consequence of obesity on these systems, it seems essential to obtain data on vitamin deficit correction in obese children and adolescents and to evaluate bone status of these patients using modern imaging technics (high resolution peripheral quantitative computed tomography, HRpQCT).

In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese children and adolescent will allow us for :

• evaluate vitamin D correction effect by two scheme of administration

• establish an inventory of vitamin D status in this population

• Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model

• study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself on bone, by analysing bone micro-architecture

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

• NCT number: NCT03516968
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Contact: Carine Villanueva, MD
• Phone: 4 27 85 53 28
• Email: carine.villanueva@chu-lyon.fr
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2023
• Completion date: April 2026