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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Vitamin D supplementation; Drug: Placebo; Other: 3 months lifestyle and dietary management; Other: Normal control

Study type: Interventional

Funder types: Other

Identifiers

NCT02400151

2015-000060-34 (EudraCT Number)

LOCAL/2015/APM-01

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 49 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

General 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

Inclusion criteria for the patient population

• 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

Inclusion criteria for the control population

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 3 patient groups, including a placebo group

Non-Obese group

Other group

Description:

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

Treatment:

Other: Normal control

Obese group, Vitamin D

Experimental group

Description:

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

Treatment:

Other: 3 months lifestyle and dietary management

Drug: Vitamin D supplementation

Obese group, placebo

Placebo Comparator group

Description:

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

Treatment:

Other: 3 months lifestyle and dietary management

Drug: Placebo