Vitamin D Needs of Early Adolescent Children

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT00931580
• Lead Sponsor: University of Georgia

Brief 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.

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Study Start: 2009-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Healthy
• Non-Hispanic
• Male, 10-13 years of age or female 9-11 years of age
• Within genitalia or breast stage 2/3
• Willing to provide blood/urine samples
• Free from taking vitamin, mineral or herbal supplements
• Able to swallow tablets

Exclusion Criteria

• Menarche (females)
• Known bone diseases or disease known to influence bone metabolism (e.g. cerebral palsy, intestinal malabsorption, juvenile rheumatoid arthritis)
• Known growth disorder
• The use of medications that influence bone metabolism (e.g. corticosteroids, Attention Deficit Hyperactivity Disorder (ADHD) medications).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 IU	Vitamin D3	Vitamin D3 tablet, 400 IU
1,000 IU	Vitamin D3	Vitamin D3 tablet, 1,000 IU
4,000 IU	Vitamin D3	Vitamin D3 tablet, 4,000 IU
Placebo	Vitamin D3	placebo tablet
2,000 IU	Vitamin D3	Vitamin D3 tablet, 2,000 IU

Primary Outcome Measures

Name	Time	Method
PTH	12 weeks
1,25(OH)2D	12 weeks
fractional calcium absorption	12 weeks
biochemical markers of bone turnover	12 weeks
serum 25(OH)D	12 weeks

Secondary Outcome Measures

Name	Time	Method
serum and urinary calcium	12 weeks
physical activity data	12 weeks
body composition	12 weeks
sunlight exposure	12 weeks
dietary data	12 weeks

Trial Locations

Locations (3)

The University of Georgia Dept of Foods & Nutrition; 🇺🇸 Athens, Georgia, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Purdue University; 🇺🇸 West Lafayette, Indiana, United States