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ObesityPhase 4VIDADONCT02400151

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

A Phase 4 study testing Vitamin D supplementation and 3 months lifestyle and dietary management in people with Obesity, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Vitamin D supplementation and 3 months lifestyle and dietary management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
2 sitesFrance
Study dates
30 Mar 2015to 4 Jul 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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 locations and contacts

2 sites in 1 country.

France2 sites

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Institut Saint Pierre

    Palavas-les-Flots, 34250

Other trials in France

About this study

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

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).

Read the detailed description

The secondary objectives of this study are:

  1. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation on metabolic and vascular function.
  2. To compare the relationships between food intake, metabolic, inflammatory, oxidative stress and vitamin D status, and vascular dysfunction between obese and normal weight subjects.
  3. 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.
  4. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin D deficiency and vascular function.
  5. To evaluate in obese adolescents, the effects of vitamin D supplementation on the metabolome (metabolic signature).
  6. 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.

  1. Establish a biobank of samples taken at baseline and at 3 months.
Conditions
Obesity
Being tested
Vitamin D supplementation, Placebo, 3 months lifestyle and dietary management, Normal control
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D supplementationDrug

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

  • PlaceboDrug

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

  • 3 months lifestyle and dietary managementOther

    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 controlOther

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

Study groups in NCT02400151
Study groupRoleWhat they receive
Non-Obese groupOtherNon-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation. Intervention: Normal control
Receives: Other: Normal control
Obese group, Vitamin DExperimentalSubjects 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
Receives: Drug: Vitamin D supplementation; Other: 3 months lifestyle and dietary management
Obese group, placeboPlacebo comparatorSubjects 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
Receives: Drug: Placebo; Other: 3 months lifestyle and dietary management

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months

Secondary outcomes (26)

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  5. Usual Vitamin D intake according to food questionnaire

    Measured: Baseline

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  10. Change from baseline in Homeostatic model assessment Insulin Resistance

    Measured: 3 months

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

    Measured: 3 months

  12. Change from baseline in Triglyceride levels

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  25. Metabolomic profile

    Measured: baseline

  26. Metabolomic profile

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2015 (estimated)
  2. Study start30 Mar 2015
  3. Primary completion4 Jul 2016
  4. Study completion4 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02400151
Sponsor's protocol ID
LOCAL/2015/APM-01
Other IDs
2015-000060-34, 2015
Acronym
VIDADO
Status last verified
Jun 2017
First submitted
23 Mar 2015
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34090775

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitamin D supplementation and 3 months lifestyle and dietary management in people with Obesity, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Flow Mediated Dilation (%) at the brachial artery (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02400151, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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