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Completed

NCT Number: NCT02400151

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

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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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D supplementation

Drug

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

Placebo

Drug

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

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.

Normal control

Other

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

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

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

    Time frame: 3 months

  5. Usual Vitamin D intake according to food questionnaire

    Time frame: Baseline

  6. Change from baseline in blood 25(OH)D levels (mmol*L^-1)

    Time frame: 3 months

  7. Change from baseline in blood parathyroid hormone levels (mmol*L^-1)

    Time frame: 3 months

  8. Change from baseline in serum calcium levels (mmol*L^-1)

    Time frame: 3 months

  9. Change from baseline in blood total protein levels (g*L^-1)

    Time frame: 3 months

  10. Change from baseline in Homeostatic model assessment Insulin Resistance

    Time frame: 3 months

  11. Change from baseline in the ratio Low Density Lipoprotein/High Density Lipoprotein

    Time frame: 3 months

  12. Change from baseline in Triglyceride levels

    Time frame: 3 months

  13. Change from baseline in Acetylcholine-Cutaneous Blood Flow peak

    Time frame: 3 months

  14. Change from baseline in Sodium nitroprussiate-Cutaneous Blood Flow peak (%)

    Time frame: 3 months

  15. Change from baseline in Insulin-Cutaneous Blood Flow peak (%)

    Time frame: 3 months

  16. Change from baseline in TNF-alpha (pg*mL^-1)

    Time frame: 3 months

  17. Change from baseline in IL-6 (pg*mL^-1)

    Time frame: 3 months

  18. Change from baseline in High sensitivity C-reactive protein (pg*mL^-1)

    Time frame: 3 months

  19. Change from baseline in leptin (pg*mL^-1)

    Time frame: 3 months

  20. Change from baseline in adiponectin (pg*mL^-1)

    Time frame: 3 months

  21. Change from baseline in SuperOxyde Dismutase (U*gHb^-1)

    Time frame: 3 months

  22. Change from baseline in Isoprostanes (ng*L^-1)

    Time frame: 3 months

  23. Change from baseline in nitrite-nitrate (µmol*L^-1)

    Time frame: 3 months

  24. Change from baseline in PAI-1 (µmol*L^-1)

    Time frame: 3 months

  25. Metabolomic profile

    Time frame: baseline

  26. Metabolomic profile

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • EA4278 PEC Laboratoire de Pharm-Ecologie Cardiovasculaire
  • UMR1260 NORT Nutrition, Obésité et Risque Thrombotique

Registry information

Official study title

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

Acronym: VIDADO

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2015
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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