Defining Vitamin D Insufficiency

Defining Vitamin D Insufficiency in School-Age Children:  A Randomized Placebo-Controlled Trial of Vitamin D3

Protocol Description

The purpose of this study is to find out the levels of vitamin D associated with vitamin D insufficiency (low vitamin D status) in school-age children. Results will help to show prevalence of low vitamin D levels in children and how vitamin D levels affect their bone health. Vitamin D is important for keeping bones healthy and strong. Vitamin D is produced by the body when sunlight touches the skin. In the northern United States, in places such as Pittsburgh, the potential for vitamin D insufficiency is greater during winter because of reduced exposure to sunlight. Vitamin D levels may be lower among people with darker skin. Dark skinned individuals have more melanin in their skin, and melanin acts as a natural sunscreen. Vitamin D insufficiency during childhood has the potential to impact an individual’s achievement of peak bone mass.

Eligibility Criteria

This study will enroll healthy Caucasian and African-American children of both genders, ages 8 to 14.
Boys: Ages 8 to 14 years
Girls: Ages 8 to 14 years

Participants will complete 3 office visits over a 6-month period.  Study visits will include physical examination for assessment of pubertal status, estimation of skin color, blood draws, assessment of calcium and vitamin D intake and sunlight exposure. Participants will be randomly assigned to take a vitamin D pill or placebo daily for the duration of the study, and parents will need to provide a 3-day record of their child’s food and beverage intake.
Visits: 3
Duration: 6 months

Status: Closed to Enrollment

Source of Support
National Institutes of Health

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Kumaravel Rajakumar, MD

Contact Information

To get started, please contact:
Kumaravel Rajakumar, MD

Last Update
August 16, 2013
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Last Update
August 16, 2013