Vitamin D Needs of Early Adolescent Children

NCT00931580 | Completed DMC

• 2 other identifiers: 1R01HD57126-01A2 UGA1R01HD057126-01A2
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Keywords

Vitamin D; Adolescent; African American; White

Outcome Measures

Primary Outcomes (22)

• serum 25(OH)D

  0 weeks

• PTH

  0 weeks

• 1,25(OH)2D

  0 weeks

• fractional calcium absorption

  0 weeks

• biochemical markers of bone turnover

  0 weeks

• serum 25(OH)D

  3 weeks

• serum 25(OH)D

  6 weeks

• serum 25(OH)D

  9 weeks

• serum 25(OH)D

  12 weeks

• PTH

  3 weeks

• PTH

  6 weeks

• PTH

  9 weeks

• PTH

  12 weeks

• 1,25(OH)2D

  3 weeks

• 1,25(OH)2D

  6 weeks

• 1,25(OH)2D

  9 weeks

• 1,25(OH)2D

  12 weeks

• fractional calcium absorption

  12 weeks

• biochemical markers of bone turnover

  3 weeks

• biochemical markers of bone turnover

  6 weeks

• biochemical markers of bone turnover

  9 weeks

• biochemical markers of bone turnover

  12 weeks

Secondary Outcomes (25)

• sunlight exposure

  0 weeks

• dietary data

  0 weeks

• physical activity data

  0 weeks

• serum and urinary calcium

  0 weeks

• body composition

  0 weeks

Study Arms (5)

Placebo

PLACEBO COMPARATOR

placebo tablet

Dietary Supplement: Vitamin D3

400 IU

EXPERIMENTAL

Vitamin D3 tablet, 400 IU

Dietary Supplement: Vitamin D3

1,000 IU

EXPERIMENTAL

Vitamin D3 tablet, 1,000 IU

Dietary Supplement: Vitamin D3

2,000 IU

EXPERIMENTAL

Vitamin D3 tablet, 2,000 IU

Dietary Supplement: Vitamin D3

4,000 IU

EXPERIMENTAL

Vitamin D3 tablet, 4,000 IU

Dietary Supplement: Vitamin D3

Interventions

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

1,000 IU; 2,000 IU; 4,000 IU; 400 IU; Placebo

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Georgia: lead
• Purdue University: collaborator
• Indiana University School of Medicine: collaborator

Study Sites (3)

The University of Georgia Dept of Foods & Nutrition

Athens, Georgia, 30602, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (5)

• 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.

  PMID: 24092833 RESULT

• 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.

  PMID: 30001469 DERIVED

• 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.

  PMID: 28286536 DERIVED

• 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.

  PMID: 26885880 DERIVED

• 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.

  PMID: 22750015 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Richard D Lewis, PhD

  The University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 25, 2015

Record last verified: 2015-09

Locations

US (3)