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Completed

NCT Number: NCT00931580

Vitamin D Needs of Early Adolescent Children

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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Key information

Conditions

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vitamin D3

Dietary Supplement

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

Primary outcomes

  1. serum 25(OH)D

    Time frame: 0 weeks

  2. PTH

    Time frame: 0 weeks

  3. 1,25(OH)2D

    Time frame: 0 weeks

  4. fractional calcium absorption

    Time frame: 0 weeks

  5. biochemical markers of bone turnover

    Time frame: 0 weeks

  6. serum 25(OH)D

    Time frame: 3 weeks

  7. serum 25(OH)D

    Time frame: 6 weeks

  8. serum 25(OH)D

    Time frame: 9 weeks

  9. serum 25(OH)D

    Time frame: 12 weeks

  10. PTH

    Time frame: 3 weeks

  11. PTH

    Time frame: 6 weeks

  12. PTH

    Time frame: 9 weeks

  13. PTH

    Time frame: 12 weeks

  14. 1,25(OH)2D

    Time frame: 3 weeks

  15. 1,25(OH)2D

    Time frame: 6 weeks

  16. 1,25(OH)2D

    Time frame: 9 weeks

  17. 1,25(OH)2D

    Time frame: 12 weeks

  18. fractional calcium absorption

    Time frame: 12 weeks

  19. biochemical markers of bone turnover

    Time frame: 3 weeks

  20. biochemical markers of bone turnover

    Time frame: 6 weeks

  21. biochemical markers of bone turnover

    Time frame: 9 weeks

  22. biochemical markers of bone turnover

    Time frame: 12 weeks

Secondary outcomes

  1. sunlight exposure

    Time frame: 0 weeks

  2. dietary data

    Time frame: 0 weeks

  3. physical activity data

    Time frame: 0 weeks

  4. serum and urinary calcium

    Time frame: 0 weeks

  5. body composition

    Time frame: 0 weeks

  6. sunlight exposure

    Time frame: 3 weeks

  7. sunlight exposure

    Time frame: 6 weeks

  8. sunlight exposure

    Time frame: 9 weeks

  9. sunlight exposure

    Time frame: 12 weeks

  10. dietary data

    Time frame: 3 weeks

  11. dietary data

    Time frame: 6 weeks

  12. dietary data

    Time frame: 9 weeks

  13. dietary data

    Time frame: 12 weeks

  14. physical activity data

    Time frame: 3 weeks

  15. physical activity data

    Time frame: 6 weeks

  16. physical activity data

    Time frame: 9 weeks

  17. physical activity data

    Time frame: 12 weeks

  18. serum and urinary calcium

    Time frame: 3 weeks

  19. serum and urinary calcium

    Time frame: 6 weeks

  20. serum and urinary calcium

    Time frame: 9 weeks

  21. serum and urinary calcium

    Time frame: 12 weeks

  22. body composition

    Time frame: 3 weeks

  23. body composition

    Time frame: 6 weeks

  24. body composition

    Time frame: 9 weeks

  25. body composition

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Indiana University
  • Purdue University

Registry information

Official study title

Supplemental Vitamin D and Functional Outcomes in Early Adolescence

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2009
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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