View Clinical Trial (Medical Research Study)
Supplemental Vitamin D and Functional Outcomes in Early Adolescence
| City: |
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West Lafayette |
| State: |
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Indiana |
| Zip Code: |
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47907 |
| Conditions: |
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Healthy |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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).
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| NCT ID: |
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NCT00931580 |
| Primary Contact: |
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Principal Investigator
Richard D Lewis, PhD
The University of Georgia
Richard D Lewis, PhD
Phone: 706-542-4901
Email: rlewis@fcs.uga.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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West Lafayette, Indiana 47907
United States
Connie Weaver, PhD
Phone: 765-494-8231
Email: weavercm@purdue.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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