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

NCT02400151 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-11-19

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • UMR1260 NORT Nutrition, Obésité et Risque Thrombotique

    collaborator UNKNOWN

  • EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Antonia Perez Martin, MD, PhD · Centre Hospitalier Universitaire de Nîmes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2016-07-04
Completion
2016-07-04

Countries

  • France

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400151 on ClinicalTrials.gov