Vitamin D Needs of Early Adolescent Children
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 9 - 13 |
| Updated: | 4/21/2016 |
| Start Date: | October 2009 |
| End Date: | April 2011 |
Supplemental Vitamin D and Functional Outcomes in Early Adolescence
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.
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.
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.
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.
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).
We found this trial at
3
sites
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340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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