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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-30

Study Completion Date

2016-07-04

Brief Summary

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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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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Non-Obese group

Non-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation.

Intervention: Normal control

Group Type OTHER

Normal control

Intervention Type OTHER

Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.

Obese group, Vitamin D

Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.

Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation

Group Type EXPERIMENTAL

Vitamin D supplementation

Intervention Type DRUG

Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.

3 months lifestyle and dietary management

Intervention Type OTHER

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.

Obese group, placebo

Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France.

Intervention: 3 months lifestyle and dietary management Intervention: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients randomized to this group will receive placebo for 90 days.

3 months lifestyle and dietary management

Intervention Type OTHER

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.

Interventions

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Vitamin D supplementation

Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.

Intervention Type DRUG

Placebo

Patients randomized to this group will receive placebo for 90 days.

Intervention Type DRUG

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.

Intervention Type OTHER

Normal control

Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient's legal representatives must have given their informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Sexual maturation of at least Tanner stage 2

* The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)
* Absence of at least 5% of total weight over the last 3 months

* The subject has a body mass index \< 90th percentile

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* The patient's legal representative(s) refuse(s) to sign the consent
* It is impossible to correctly inform the patient or his/her legal representative(s)
* The patient has a contraindication for physical activity (joint, heart or other)
* The subject does at least 3 hours of extracurricular physical activity per week
* The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).
* Active smoking
* Known dyslipidemia (particularly hypercholesterolemia).
* The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).
* BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.
* Secondary or known genetic obesity.
* Known hypersensitivity to vitamin D.
* Hypercalcemia, hypercalciuria, calcium lithiasis

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes