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

NCT02400151 | Completed Phase 4

• 2 other identifiers: LOCAL/2015/APM-012015-000060-34
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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

Obesity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Flow Mediated Dilation (%) at the brachial artery

  3 months

Secondary Outcomes (26)

• Change from baseline in Nitrate Mediated Dilation (%) at the brachial artery

  3 months

• Change from baseline in carotid compliance (mm^2mmHg^-1)

  3 months

• Change from baseline in brachial compliance (mm^2mmHg^-1)

  3 months

• Change from baseline in arterial wave speed (m*s^-1)

  3 months

• Usual Vitamin D intake according to food questionnaire

  Baseline

Study Arms (3)

Non-Obese group

OTHER

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

Other: Normal control

Obese group, Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D supplementation; Other: 3 months lifestyle and dietary management

Obese group, placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Other: 3 months lifestyle and dietary management

Interventions

Vitamin D supplementation DRUG

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

Obese group, Vitamin D

Placebo DRUG

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

Obese group, placebo

3 months lifestyle and dietary management 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, Vitamin D; Obese group, placebo

Normal control OTHER

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

Non-Obese group

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• UMR1260 NORT Nutrition, Obésité et Risque Thrombotique: collaborator
• EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire: collaborator

Study Sites (2)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Institut Saint Pierre

Palavas-les-Flots, 34250, France

Location

Related Publications (1)

• Vinet A, Morrissey C, Perez-Martin A, Goncalves A, Raverdy C, Masson D, Gayrard S, Carrere M, Landrier JF, Amiot MJ. Effect of vitamin D supplementation on microvascular reactivity in obese adolescents: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2021 Jul 22;31(8):2474-2483. doi: 10.1016/j.numecd.2021.04.025. Epub 2021 May 10.

  PMID: 34090775 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Antonia Perez Martin, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 30, 2015
• Primary Completion: July 4, 2016
• Study Completion: July 4, 2016
• Last Updated: November 19, 2025

Record last verified: 2017-06

Locations

FR (2)