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

Completed · Phase 2

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00858247

Run by

Mayo Clinic

People needed

51

Starts

2009-04-01

Expected to finish

2012-12-01

Last updated by the study team

2014-05-20

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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