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Vitamin D Needs of Early Adolescent Children

Supplemental Vitamin D and Functional Outcomes in Early Adolescence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00931580
Enrollment
323
Registered
2009-07-02
Start date
2009-10-31
Completion date
2011-04-30
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Vitamin D, Adolescent, African American, White

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks

Sponsors

Purdue University
CollaboratorOTHER
Indiana University School of Medicine
CollaboratorOTHER
University of Georgia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
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).

Design outcomes

Primary

MeasureTime frame
fractional calcium absorption0 weeks
biochemical markers of bone turnover0 weeks
serum 25(OH)D0 weeks
PTH0 weeks
1,25(OH)2D0 weeks

Secondary

MeasureTime frame
sunlight exposure0 weeks
dietary data0 weeks
physical activity data0 weeks
serum and urinary calcium0 weeks
body composition0 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026