Clinical trial NCT00931580: Vitamin D Needs of Early Adolescent Children
Official title: Supplemental Vitamin D and Functional Outcomes in Early Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vitamin D
Adolescent
African American
White
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Indiana University School of Medicine
First posted: 2009-07-02
Enrollment: 323
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: serum 25(OH)D
timeFrame: 0 weeks
measure: PTH
timeFrame: 0 weeks
measure: 1,25(OH)2D
timeFrame: 0 weeks
measure: fractional calcium absorption
timeFrame: 0 weeks
measure: biochemical markers of bone turnover
timeFrame: 0 weeks
measure: serum 25(OH)D
timeFrame: 3 weeks
measure: serum 25(OH)D
timeFrame: 6 weeks
measure: serum 25(OH)D
timeFrame: 9 weeks
measure: serum 25(OH)D
timeFrame: 12 weeks
measure: PTH
timeFrame: 3 weeks
measure: PTH
timeFrame: 6 weeks
measure: PTH
timeFrame: 9 weeks
measure: PTH
timeFrame: 12 weeks
measure: 1,25(OH)2D
timeFrame: 3 weeks
measure: 1,25(OH)2D
timeFrame: 6 weeks
measure: 1,25(OH)2D
timeFrame: 9 weeks
measure: 1,25(OH)2D
timeFrame: 12 weeks
measure: fractional calcium absorption
timeFrame: 12 weeks
measure: biochemical markers of bone turnover
timeFrame: 3 weeks
measure: biochemical markers of bone turnover
timeFrame: 6 weeks
measure: biochemical markers of bone turnover
timeFrame: 9 weeks
measure: biochemical markers of bone turnover
timeFrame: 12 weeks
Secondary outcomes:
measure: sunlight exposure
timeFrame: 0 weeks
measure: dietary data
timeFrame: 0 weeks
measure: physical activity data
timeFrame: 0 weeks
measure: serum and urinary calcium
timeFrame: 0 weeks
measure: body composition
timeFrame: 0 weeks
measure: sunlight exposure
timeFrame: 3 weeks
measure: sunlight exposure
timeFrame: 6 weeks
measure: sunlight exposure
timeFrame: 9 weeks
measure: sunlight exposure
timeFrame: 12 weeks
measure: dietary data
timeFrame: 3 weeks
measure: dietary data
timeFrame: 6 weeks
measure: dietary data
timeFrame: 9 weeks
measure: dietary data
timeFrame: 12 weeks
measure: physical activity data
timeFrame: 3 weeks
measure: physical activity data
timeFrame: 6 weeks
measure: physical activity data
timeFrame: 9 weeks
measure: physical activity data
timeFrame: 12 weeks
measure: serum and urinary calcium
timeFrame: 3 weeks
measure: serum and urinary calcium
timeFrame: 6 weeks
measure: serum and urinary calcium
timeFrame: 9 weeks
measure: serum and urinary calcium
timeFrame: 12 weeks
measure: body composition
timeFrame: 3 weeks
measure: body composition
timeFrame: 6 weeks
measure: body composition
timeFrame: 9 weeks
measure: body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: The University of Georgia Dept of Foods & Nutrition
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: The University of Georgia
name: Richard D Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.