Vitamin D Needs of Early Adolescent Children

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo tablet	Dietary supplement: Vitamin D3; vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
Experimental: 400 IU; Vitamin D3 tablet, 400 IU	Dietary supplement: Vitamin D3; vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
Experimental: 1,000 IU; Vitamin D3 tablet, 1,000 IU	Dietary supplement: Vitamin D3; vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
Experimental: 2,000 IU; Vitamin D3 tablet, 2,000 IU	Dietary supplement: Vitamin D3; vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
Experimental: 4,000 IU; Vitamin D3 tablet, 4,000 IU	Dietary supplement: Vitamin D3; vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
body composition	12 weeks
sunlight exposure	0 weeks
dietary data	0 weeks
physical activity data	0 weeks
serum and urinary calcium	0 weeks
body composition	0 weeks
sunlight exposure	3 weeks
sunlight exposure	6 weeks
sunlight exposure	9 weeks
sunlight exposure	12 weeks
dietary data	3 weeks
dietary data	6 weeks
dietary data	9 weeks
dietary data	12 weeks
physical activity data	3 weeks
physical activity data	6 weeks
physical activity data	9 weeks
physical activity data	12 weeks
serum and urinary calcium	3 weeks
serum and urinary calcium	6 weeks
serum and urinary calcium	9 weeks
serum and urinary calcium	12 weeks
body composition	3 weeks
body composition	6 weeks
body composition	9 weeks

Collaborators and Investigators

• Sponsor: University of Georgia
• Collaborators: Purdue University; Indiana University School of Medicine
• Investigators: Principal Investigator: Richard D Lewis, PhD, The University of Georgia

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Adolescent; Vitamin D; African American; White
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 1R01HD57126-01A2 UGA