NCT02400151

Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents

Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).

Detailed description

The secondary objectives of this study are: A. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation on metabolic and vascular function. B. To compare the relationships between food intake, metabolic, inflammatory, oxidative stress and vitamin D status, and vascular dysfunction between obese and normal weight subjects. C. To evaluate the effects of sun exposure variations on relationships described in Objective B by comparing the observed parameters at baseline and at the end of the three month follow-up period, in non-supplemented obese adolescents and adolescents of normal weight. D. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin D deficiency and vascular function. E. To evaluate in obese adolescents, the effects of vitamin D supplementation on the metabolome (metabolic signature). F. To evaluate the effects of lifestyle and dietary management on these biomarkers (in the "control group"). For these targets (A to F), all teenagers will be classified according to three levels of skin pigmentation. G. Establish a biobank of samples taken at baseline and at 3 months.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Vitamin D supplementation	Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
DRUG	Placebo	Patients randomized to this group will receive placebo for 90 days.
OTHER	3 months lifestyle and dietary management	Lifestyle and dietary management at the Saint Pierre Institute (Palavas-les-Flots, France) occurs for three months. Nutritionally speaking, each child or adolescent receives a controlled and balanced diet, consistent with the recommendations appropriate for his/her age, slightly hypocaloric or normocaloric. This dietary approach is complemented by a nutrition education program and supervision by a doctor and a dietician. Three hours of exercise training per week are scheduled; these sessions include adapted aerobic activities supervised by instructors and educators at the center.
OTHER	Normal control	Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.

Timeline

• Start date: 2015-03-30
• Primary completion: 2016-07-04
• Completion: 2016-07-04
• First posted: 2015-03-26
• Last updated: 2025-11-19

Locations

2 sites across 1 country: France