Vitamin D Needs of Early Adolescent Children

This study has been completed.
Sponsor:
Collaborators:
Purdue University
Indiana University School of Medicine
Information provided by (Responsible Party):
Dr. Richard D. Lewis, University of Georgia
ClinicalTrials.gov Identifier:
NCT00931580
First received: July 1, 2009
Last updated: September 23, 2015
Last verified: September 2015

July 1, 2009
September 23, 2015
October 2009
April 2011   (final data collection date for primary outcome measure)
  • serum 25(OH)D [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • fractional calcium absorption [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • serum 25(OH)D [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • serum 25(OH)D [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • serum 25(OH)D [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • serum 25(OH)D [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • fractional calcium absorption [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • serum 25(OH)D [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • PTH [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • 1,25(OH)2D [ Time Frame: 0,3,6,9 and 12 weeks ] [ Designated as safety issue: Yes ]
  • fractional calcium absorption [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • biochemical markers of bone turnover [ Time Frame: 0,3,6,9 and 12 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00931580 on ClinicalTrials.gov Archive Site
  • sunlight exposure [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 0 weeks ] [ Designated as safety issue: Yes ]
  • sunlight exposure [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • sunlight exposure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • sunlight exposure [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • sunlight exposure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • sunlight exposure [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • dietary data [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • physical activity data [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • serum and urinary calcium [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
  • body composition [ Time Frame: 0,3,6,9, and 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
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
  • Placebo Comparator: Placebo
    placebo tablet
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: 400 IU
    Vitamin D3 tablet, 400 IU
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: 1,000 IU
    Vitamin D3 tablet, 1,000 IU
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: 2,000 IU
    Vitamin D3 tablet, 2,000 IU
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: 4,000 IU
    Vitamin D3 tablet, 4,000 IU
    Intervention: Dietary Supplement: Vitamin D3

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
April 2011
April 2011   (final data collection date for primary outcome measure)

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).
Both
9 Years to 13 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00931580
1R01HD57126-01A2 UGA
Yes
Not Provided
Not Provided
Dr. Richard D. Lewis, University of Georgia
University of Georgia
  • Purdue University
  • Indiana University School of Medicine
Principal Investigator: Richard D Lewis, PhD The University of Georgia
University of Georgia
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP