Vitamin D Needs of Early Adolescent Children

Sponsor

University of Georgia (Other)

Overall Status

Completed

CT.gov ID

NCT00931580

Collaborator

Purdue University (Other), Indiana University School of Medicine (Other)

323

Enrollment

Locations

Arms

Duration (Months)

107.7

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Vitamin D3	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

323 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

Supplemental Vitamin D and Functional Outcomes in Early Adolescence

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo placebo tablet	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
Experimental: 400 IU Vitamin D3 tablet, 400 IU	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
Experimental: 1,000 IU Vitamin D3 tablet, 1,000 IU	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
Experimental: 2,000 IU Vitamin D3 tablet, 2,000 IU	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
Experimental: 4,000 IU Vitamin D3 tablet, 4,000 IU	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

Outcome Measures

Primary Outcome Measures

serum 25(OH)D [0 weeks]
PTH [0 weeks]
1,25(OH)2D [0 weeks]
fractional calcium absorption [0 weeks]
biochemical markers of bone turnover [0 weeks]
serum 25(OH)D [3 weeks]
serum 25(OH)D [6 weeks]
serum 25(OH)D [9 weeks]
serum 25(OH)D [12 weeks]
PTH [3 weeks]
PTH [6 weeks]
PTH [9 weeks]
PTH [12 weeks]
1,25(OH)2D [3 weeks]
1,25(OH)2D [6 weeks]
1,25(OH)2D [9 weeks]
1,25(OH)2D [12 weeks]
fractional calcium absorption [12 weeks]
biochemical markers of bone turnover [3 weeks]
biochemical markers of bone turnover [6 weeks]
biochemical markers of bone turnover [9 weeks]
biochemical markers of bone turnover [12 weeks]

Secondary Outcome Measures

sunlight exposure [0 weeks]
dietary data [0 weeks]
physical activity data [0 weeks]
serum and urinary calcium [0 weeks]
body composition [0 weeks]
sunlight exposure [3 weeks]
sunlight exposure [6 weeks]
sunlight exposure [9 weeks]
sunlight exposure [12 weeks]
dietary data [3 weeks]
dietary data [6 weeks]
dietary data [9 weeks]
dietary data [12 weeks]
physical activity data [3 weeks]
physical activity data [6 weeks]
physical activity data [9 weeks]
physical activity data [12 weeks]
serum and urinary calcium [3 weeks]
serum and urinary calcium [6 weeks]
serum and urinary calcium [9 weeks]
serum and urinary calcium [12 weeks]
body composition [3 weeks]
body composition [6 weeks]
body composition [9 weeks]
body composition [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Georgia Dept of Foods & Nutrition	Athens	Georgia	United States	30602
2	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
3	Purdue University	West Lafayette	Indiana	United States	47907