Clinical Trials

Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents have a high prevalence of Vitamin D deficiency as well as evidence of endothelial dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with Vitamin D would lead to improvement in endothelial dysfunction.

Who is eligible to participate?

Inclusion Criteria:

1. Age 12-18 years

2. BMI >95% for age and gender

3. 25 (OH) D levels less than 30 ng/ml

Exclusion Criteria:

1. 25 (OH) D levels >30 ng/mL

2. Serum calcium >10.4 mg/dL

3. Serum phosphorus > 4.7 mg/dl

4. Pregnancy or nursing

5. Current cancer

6. Patients on vitamin D3 supplementation exceeding 400 IU/day

7. Hypertension defined as Blood Pressure over the 95th percentile for age, gender and height

8. Dietary calcium intake exceeding 1500 mg/day,

9. Hepatic or renal disorders

10. Type 1 or type 2 diabetes mellitus

11. Subjects receiving insulin, metformin, or oral hypoglycemic medications

12. Subjects with malabsorption disorders (celiac disease, cystic fibrosis,inflammatory bowel disease)

Last updated: 01/15/2013

NCT ID: NCT01746264

IRB Number:12-006349