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

NCT00858247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-05-20

Study results available
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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. 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

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.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Thrasher Research Fund

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Seema Kumar, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00858247 on ClinicalTrials.gov