NCT00931580

Vitamin D Needs of Early Adolescent Children

Supplemental Vitamin D and Functional Outcomes in Early Adolescence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: University of Georgia · Academic / Other
• Sex: All
• Age: 9 Years – 13 Years
• Healthy volunteers: Accepted

Summary

While a large percentage of children have low blood vitamin D levels, the significance of these low levels and the impact on health is unclear. The purpose of this project is to determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood indicators of health in white and black children, aged 9 to 13 years, from both the northern and southern US.

Detailed description

Vitamin D intakes in children do not meet current US Dietary Reference Intake recommendations and emerging evidence suggests that a significant number of children, particularly those with darker skin pigmentation, have inadequate levels of serum 25-hydroxyvitamin D \[25(OH)D\]. The optimum level of circulating 25(OH)D has not been clearly defined in children, nor is it known what functional outcome measures are ideal for defining this level, or if these requirements would differ by race. Graded doses of vitamin D3 supplementation will be used in this dual-site, 12-week trial. The investigators hypothesize that a dose-response relationship will be observed between vitamin D supplementation and intermediate endpoints of skeletal health, and that race will modify these responses.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D3	vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-07-02
• Last updated: 2015-09-25

Locations

3 sites across 1 country: United States