Vitamin D supplementation
DrugPatients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
NCT Number: NCT02400151
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).
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Notify Me11 year–17 year
All sexes
Interventional
Phase 4
CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
General Inclusion Criteria:
Inclusion criteria
for the patient population
Inclusion criteria
for the control population
Exclusion criteria
Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
Patients randomized to this group will receive placebo for 90 days.
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.
Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.
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Time frame: baseline
Time frame: 3 months
Centre Hospitalier Universitaire de Nīmes
Other
Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial
Acronym: VIDADO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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