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ObesityPhase 2NCT00858247

Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors in Obese Adolescents

A Phase 2 study testing Vitamin D3 in people with Obesity, run by Mayo Clinic at 1 site in United States.

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 prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Apr 2009to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Age between 12-18 years
  • BMI is at or greater than the 95th percentile for age and gender

Who cannot join

  • Subjects with 25 (OH)- D levels >100 ng/mL
  • Serum calcium >10.8 mg/dL
  • Current cancer
  • Those taking a multivitamin supplementation
  • Hepatic or renal disorders
  • Type 1 or type 2 diabetes mellitus.
Show all 9Show fewer
  • Those receiving insulin, metformin or oral hypoglycemic medications
  • Use of glucocorticoids and anti-seizure medications in the previous 6 months
  • Malabsorption syndromes such as celiac disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Significance of Vitamin D Status in Obese Adolescents- A Pilot Study to Examine the Effect of Vitamin D3 Supplementation on Insulin Resistance and Cardiovascular Risk Factors

The prevalence of obesity has reached epidemic proportions nationally as well as internationally. Currently, 16 % of American adolescents are obese. In adults, obesity is a risk factor for vitamin D insufficiency and up to 80% of obese adults have been noted to vitamin D insufficient. In adults, low vitamin D status appears to be associated with the development of type 2 diabetes and metabolic syndrome. There is little information on the prevalence of vitamin D insufficiency and its implications in obese adolescents. Additionally, it is unknown whether treatment of vitamin D insufficiency in adolescents might result in improvement in insulin resistance, lipids and cardiovascular risk markers.

We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation improves insulin resistance and cardiovascular risk factors in this population. The purpose of the study is to determine the impact of vitamin D3 supplementation on various parameters of insulin secretion, insulin action, lipids and C-reactive protein in obese adolescents.

Read the detailed description

The problem of childhood obesity has reached epidemic proportions both nationally and internationally. The prevalence of obesity has tripled in the last three decades and currently 16 % of American adolescents are obese. Nearly 30% of obese adolescents demonstrate a metabolic syndrome characterized by insulin resistance and dyslipidemia. These abnormalities lead to the development of type 2 diabetes mellitus and to increased cardiovascular morbidity and mortality. Obesity is a well-known risk factor for vitamin D insufficiency and up to 80% of obese adults have been found to be insufficient in vitamin D. Observational studies in adults have shown consistent associations between low vitamin D status and prevalence of type 2 diabetes mellitus and metabolic syndrome. There is paucity of data on the prevalence of vitamin D insufficiency and its implications in obese adolescents. It is also not known whether treatment of vitamin D insufficiency in children or adults might result in improvement in insulin resistance and cardiovascular risk factors.

Hypotheses: We hypothesize that vitamin D insufficiency correlates positively with insulin resistance and cardiovascular risk in obese adolescents and that vitamin D3 supplementation decreases insulin resistance and cardiovascular risk factors in this population.

Objectives:

  1. Determine if there is any correlation between serum 25(OH)D levels and homeostasis model assessment of insulin resistance (HOMA-IR), HDL cholesterol and C-reactive protein, in obese adolescents.
  2. Study the impact of vitamin D3 supplementation on various parameters reflecting insulin action, secretion, lipids and C-reactive protein in obese adolescents.
Conditions
Obesity
Being tested
Vitamin D3
Keywords
vitamin D, Obesity, Insulin sensitivity, Adolescent Obesity
Medical subject headings
Obesity, Insulin Resistance, Pediatric Obesity

What participants receive

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

  • Vitamin D3Dietary supplement

    One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks.

Study groups in NCT00858247
Study groupRoleWhat they receive
Vitamin D3-low doseExperimentalVitamin D3 400 IU capsule, one capsule daily for 12 weeks.
Receives: Dietary Supplement: Vitamin D3
Vitamin D3-high doseExperimentalVitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
Receives: Dietary Supplement: Vitamin D3

What is being measured

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

  1. Change in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation

    Insulin resistance (IR) is a physiological condition in which cells fail to respond to the normal actions of the hormone insulin. The body produces insulin, but the cells in the body become resistant to insulin and are unable to use it as effectively, leading to hyperglycemia. Beta cells in the pancreas subsequently increase their production of insulin, further contributing to hyperinsulinemia.

    From the fasting glucose and insulin measurements, insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA -IR) as: HOMA -IR = fasting insulin concentration (µU/mL) x fasting glucose concentration (mmol/L)/22.5. High HOMA-IR scores denote increased insulin resistance.

    Measured: Baseline, 12 weeks

Secondary outcomes (5)

  1. Change in Total Cholesterol After 12 Weeks of Vitamin D Supplementation

    Less than 200 mg/dL is desirable, >200 mg/dL is borderline high, >240 mg/dL is High

    Measured: baseline, 12 weeks

  2. Change in Low Density Lipoprotein (LDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

    LDL cholesterol is considered to be the main source of cholesterol buildup and blockage in the arteries. Less than 100 mg/dL is optimal, >130 mg/dL is borderline high, >160 mg/dL is high, >190 mg/dL is very high.

    Measured: baseline, 12 weeks

  3. Change in High Density Lipoprotein (HDL) Cholesterol After 12 Weeks of Vitamin D Supplementation

    HDL (good) cholesterol protects against heart disease, so for HDL, higher numbers are better. A level less than 40 mg/dL is low and is considered a major risk factor because it increases your risk for developing heart disease. HDL levels of 60 mg/dL or more help to lower your risk for heart disease.

    Measured: baseline, 12 weeks

  4. Change in Triglycerides After 12 Weeks of Vitamin D Supplementation

    The current recommendation on fasting blood triglyceride levels: < 150 mg/dL is normal, >150 mg/dL is borderline high, and >200 mg/dL is high.

    Measured: baseline, 12 weeks

  5. Change in High-Sensitivity C-Reactive Protein After 12 Weeks of Vitamin D Supplementation

    The high-sensitivity C-reactive protein test measures your risk for heart problems. <1.0 mg/L is lowest risk, 1.0-3.0 mg/L is average risk, and >3.0 mg/L is highest risk.

    Measured: baseline, 12 weeks

Timeline

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

  1. First posted9 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858247
Sponsor's protocol ID
08-008743
Other IDs
UL1RR024150
Status last verified
May 2014
First submitted
5 Mar 2009
Last updated
20 May 2014
Data monitoring committee
Yes

Publications

  • Javed A, Vella A, Balagopal PB, Fischer PR, Weaver AL, Piccinini F, Dalla Man C, Cobelli C, Giesler PD, Laugen JM, Kumar S. Cholecalciferol supplementation does not influence beta-cell function and insulin action in obese adolescents: a prospective double-blind randomized trial. J Nutr. 2015 Feb;145(2):284-90. doi: 10.3945/jn.114.202010. Epub 2014 Dec 17.

    PubMed 25644349

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin D3 in people with Obesity, run by Mayo Clinic at 1 site in United States.

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 2 inclusion and 9 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Insulin Resistance After 12 Weeks of Vitamin D3 Supplementation (time frame: Baseline, 12 weeks). 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 NCT00858247, 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 20 May 2014.

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