At a glance
ClinicalIndex Comparison Record- ✓Age 12-18 years
- ✓BMI at or above 95th percentile for age and gender
- ✕Baseline 25(OH)D level >100 ng/mL
- ✕Serum calcium >10.8 mg/dL
- ✕Current cancer diagnosis
- ✕Currently taking multivitamin supplementation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Vitamin D3 for Obesity. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.