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

PHASE4CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

March 30, 2015

Primary Completion Date

June 24, 2016

Study Completion Date

June 24, 2016

Conditions
Obesity
Interventions
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.

Trial Locations (2)

30029

CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes

34250

Institut Saint Pierre, Palavas-les-Flots

All Listed Sponsors
collaborator

UMR1260 NORT Nutrition, Obésité et Risque Thrombotique

UNKNOWN

collaborator

EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire

UNKNOWN

lead

Centre Hospitalier Universitaire de Nīmes

OTHER

NCT02400151 - Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents | Biotech Hunter | Biotech Hunter