49
Participants
Start Date
March 30, 2015
Primary Completion Date
June 24, 2016
Study Completion Date
June 24, 2016
Vitamin D supplementation
Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
Placebo
Patients randomized to this group will receive placebo for 90 days.
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.
Normal control
Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.
CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes
Institut Saint Pierre, Palavas-les-Flots
UMR1260 NORT Nutrition, Obésité et Risque Thrombotique
UNKNOWN
EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire
UNKNOWN
Centre Hospitalier Universitaire de Nīmes
OTHER