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HealthyNCT00931580

Vitamin D Needs of Early Adolescent Children

A study testing Vitamin D3 in people with Healthy, run by University of Georgia at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
323 participants
Where
3 sitesUnited States
Study dates
Oct 2009to Apr 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The University of Georgia Dept of Foods & Nutrition

    Athens, Georgia, 30602

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Healthy
Being tested
Vitamin D3
Keywords
Vitamin D, Adolescent, African American, White

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Dietary supplement

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

Study groups in NCT00931580
Study groupRoleWhat they receive
PlaceboPlacebo comparatorplacebo tablet
Receives: Dietary Supplement: Vitamin D3
400 IUExperimentalVitamin D3 tablet, 400 IU
Receives: Dietary Supplement: Vitamin D3
1,000 IUExperimentalVitamin D3 tablet, 1,000 IU
Receives: Dietary Supplement: Vitamin D3
2,000 IUExperimentalVitamin D3 tablet, 2,000 IU
Receives: Dietary Supplement: Vitamin D3
4,000 IUExperimentalVitamin D3 tablet, 4,000 IU
Receives: Dietary Supplement: Vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum 25(OH)D

    Measured: 0 weeks

  2. PTH

    Measured: 0 weeks

  3. 1,25(OH)2D

    Measured: 0 weeks

  4. fractional calcium absorption

    Measured: 0 weeks

  5. biochemical markers of bone turnover

    Measured: 0 weeks

  6. serum 25(OH)D

    Measured: 3 weeks

  7. serum 25(OH)D

    Measured: 6 weeks

  8. serum 25(OH)D

    Measured: 9 weeks

  9. serum 25(OH)D

    Measured: 12 weeks

  10. PTH

    Measured: 3 weeks

  11. PTH

    Measured: 6 weeks

  12. PTH

    Measured: 9 weeks

  13. PTH

    Measured: 12 weeks

  14. 1,25(OH)2D

    Measured: 3 weeks

  15. 1,25(OH)2D

    Measured: 6 weeks

  16. 1,25(OH)2D

    Measured: 9 weeks

  17. 1,25(OH)2D

    Measured: 12 weeks

  18. fractional calcium absorption

    Measured: 12 weeks

  19. biochemical markers of bone turnover

    Measured: 3 weeks

  20. biochemical markers of bone turnover

    Measured: 6 weeks

  21. biochemical markers of bone turnover

    Measured: 9 weeks

  22. biochemical markers of bone turnover

    Measured: 12 weeks

Secondary outcomes (25)

  1. sunlight exposure

    Measured: 0 weeks

  2. dietary data

    Measured: 0 weeks

  3. physical activity data

    Measured: 0 weeks

  4. serum and urinary calcium

    Measured: 0 weeks

  5. body composition

    Measured: 0 weeks

  6. sunlight exposure

    Measured: 3 weeks

  7. sunlight exposure

    Measured: 6 weeks

  8. sunlight exposure

    Measured: 9 weeks

  9. sunlight exposure

    Measured: 12 weeks

  10. dietary data

    Measured: 3 weeks

  11. dietary data

    Measured: 6 weeks

  12. dietary data

    Measured: 9 weeks

  13. dietary data

    Measured: 12 weeks

  14. physical activity data

    Measured: 3 weeks

  15. physical activity data

    Measured: 6 weeks

  16. physical activity data

    Measured: 9 weeks

  17. physical activity data

    Measured: 12 weeks

  18. serum and urinary calcium

    Measured: 3 weeks

  19. serum and urinary calcium

    Measured: 6 weeks

  20. serum and urinary calcium

    Measured: 9 weeks

  21. serum and urinary calcium

    Measured: 12 weeks

  22. body composition

    Measured: 3 weeks

  23. body composition

    Measured: 6 weeks

  24. body composition

    Measured: 9 weeks

  25. body composition

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00931580
Sponsor's protocol ID
1R01HD57126-01A2 UGA
Other IDs
1R01HD057126-01A2
Status last verified
Sep 2015
First submitted
1 Jul 2009
Last updated
25 Sep 2015
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 in people with Healthy, run by University of Georgia at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

serum 25(OH)D (time frame: 0 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931580, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.

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