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CompletedNCT00931580Updated Sep 25, 2015

Vitamin D Needs of Early Adolescent Children

An interventional study of Vitamin D3 in Healthy, sponsored by University of Georgia. Completed at 3 sites in United States. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-25.

Sponsored by University of Georgia · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
323
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Vitamin D
  • Adolescent
  • African American
  • White
03

In context

Lead sponsor

University of Georgia is the lead sponsor of 72 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
323 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    placebo tablet

    Dietary Supplement: Vitamin D3

  • Experimental
    400 IU

    Vitamin D3 tablet, 400 IU

    Dietary Supplement: Vitamin D3

  • Experimental
    1,000 IU

    Vitamin D3 tablet, 1,000 IU

    Dietary Supplement: Vitamin D3

  • Experimental
    2,000 IU

    Vitamin D3 tablet, 2,000 IU

    Dietary Supplement: Vitamin D3

  • Experimental
    4,000 IU

    Vitamin D3 tablet, 4,000 IU

    Dietary Supplement: Vitamin D3

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

06

What researchers measure

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

07

Study locations

3 sites
  • The University of Georgia Dept of Foods & Nutrition
    Athens, Georgia 30602, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 46202, United States
  • Purdue University
    West Lafayette, Indiana 47907, United States
08

References and documents

Publications

  • Lewis RD, Laing EM, Hill Gallant KM, Hall DB, McCabe GP, Hausman DB, Martin BR, Warden SJ, Peacock M, Weaver CM. A randomized trial of vitamin D(3) supplementation in children: dose-response effects on vitamin D metabolites and calcium absorption. J Clin Endocrinol Metab. 2013 Dec;98(12):4816-25. doi: 10.1210/jc.2013-2728. Epub 2013 Oct 3. PubMed 24092833 ↗
  • Wright CS, Laing EM, Pollock NK, Hausman DB, Weaver CM, Martin BR, McCabe GP, Peacock M, Warden SJ, Hill Gallant KM, Lewis RD. Serum 25-Hydroxyvitamin D and Intact Parathyroid Hormone Influence Muscle Outcomes in Children and Adolescents. J Bone Miner Res. 2018 Nov;33(11):1940-1947. doi: 10.1002/jbmr.3550. Epub 2018 Aug 27. PubMed 30001469 ↗
  • Giudici KV, Kindler JM, Martin BR, Laing EM, McCabe GP, McCabe LD, Hausman DB, Martini LA, Lewis RD, Weaver CM, Peacock M, Hill Gallant KM. Associations among osteocalcin, leptin and metabolic health in children ages 9-13 years in the United States. Nutr Metab (Lond). 2017 Mar 7;14:25. doi: 10.1186/s12986-017-0171-9. eCollection 2017. PubMed 28286536 ↗
  • Ferira AJ, Laing EM, Hausman DB, Hall DB, McCabe GP, Martin BR, Hill Gallant KM, Warden SJ, Weaver CM, Peacock M, Lewis RD. Vitamin D Supplementation Does Not Impact Insulin Resistance in Black and White Children. J Clin Endocrinol Metab. 2016 Apr;101(4):1710-8. doi: 10.1210/jc.2015-3687. Epub 2016 Feb 17. PubMed 26885880 ↗
  • Hill KM, Laing EM, Hausman DB, Acton A, Martin BR, McCabe GP, Weaver CM, Lewis RD, Peacock M. Bone turnover is not influenced by serum 25-hydroxyvitamin D in pubertal healthy black and white children. Bone. 2012 Oct;51(4):795-9. doi: 10.1016/j.bone.2012.06.014. Epub 2012 Jun 28. PubMed 22750015 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00931580
Lead sponsor
University of Georgia
Collaborators
Purdue University, Indiana University School of Medicine
Responsible party
Dr. Richard D. Lewis (Professor, University of Georgia) — Principal investigator
First posted
Jul 2, 2009
Start date
Oct 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Sep 25, 2015

Study contacts

Richard D Lewis, PhD
principal investigator · The University of Georgia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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