Vitamin D3 Supplementation Pilot Study

Completed · Not applicable

Conditions studied: Vitamin D Deficiency

In brief

The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.

Key facts

Study ID

NCT01546103

Run by

Children's Hospital of Philadelphia

People needed

39

Starts

2011-08-01

Expected to finish

2012-09-01

Last updated by the study team

2013-01-23

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• African American
• Obese [body mass index (BMI) greater than or equal to 95th percentile for age and sex]
• Pubertal (Tanner Stage greater than 1)
• 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
• Committed to adherence to supplementation and study completion

You may not qualify if…

• Pregnancy
• Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
• Known history of hypercalcemia or hypercalciuria
• Non-English speaking, as assessments are available only in English

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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