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

Obesity Clinical Trial

— VIDADO  

Official title:

Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents: Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400151
• Other study ID #: LOCAL/2015/APM-01
• Secondary ID: 2015-000060-34
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2015
• Last updated: June 16, 2017
• Start date: March 30, 2015
• Est. completion date: June 24, 2016

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 24, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Vitamin D supplementation
Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
• 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.
• Normal control
Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	Institut Saint Pierre	Palavas-Les-Flots

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire, UMR1260 NORT Nutrition, Obésité et Risque Thrombotique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Flow Mediated Dilation (%) at the brachial artery		3 months
Secondary	Change from baseline in Nitrate Mediated Dilation (%) at the brachial artery		3 months
Secondary	Change from baseline in carotid compliance (mm^2mmHg^-1)		3 months
Secondary	Change from baseline in brachial compliance (mm^2mmHg^-1)		3 months
Secondary	Change from baseline in arterial wave speed (m*s^-1)		3 months
Secondary	Usual Vitamin D intake according to food questionnaire		Baseline
Secondary	Change from baseline in blood 25(OH)D levels (mmol*L^-1)		3 months
Secondary	Change from baseline in blood parathyroid hormone levels (mmol*L^-1)		3 months
Secondary	Change from baseline in serum calcium levels (mmol*L^-1)		3 months
Secondary	Change from baseline in blood total protein levels (g*L^-1)		3 months
Secondary	Change from baseline in Homeostatic model assessment Insulin Resistance		3 months
Secondary	Change from baseline in the ratio Low Density Lipoprotein/High Density Lipoprotein		3 months
Secondary	Change from baseline in Triglyceride levels		3 months
Secondary	Change from baseline in Acetylcholine-Cutaneous Blood Flow peak		3 months
Secondary	Change from baseline in Sodium nitroprussiate-Cutaneous Blood Flow peak (%)		3 months
Secondary	Change from baseline in Insulin-Cutaneous Blood Flow peak (%)		3 months
Secondary	Change from baseline in TNF-alpha (pg*mL^-1)		3 months
Secondary	Change from baseline in IL-6 (pg*mL^-1)		3 months
Secondary	Change from baseline in High sensitivity C-reactive protein (pg*mL^-1)		3 months
Secondary	Change from baseline in leptin (pg*mL^-1)		3 months
Secondary	Change from baseline in adiponectin (pg*mL^-1)		3 months
Secondary	Change from baseline in SuperOxyde Dismutase (U*gHb^-1)		3 months
Secondary	Change from baseline in Isoprostanes (ng*L^-1)		3 months
Secondary	Change from baseline in nitrite-nitrate (µmol*L^-1)		3 months
Secondary	Change from baseline in PAI-1 (µmol*L^-1)		3 months
Secondary	Metabolomic profile		baseline
Secondary	Metabolomic profile		3 months