Vitamin D Needs of Early Adolescent Children

This study is ongoing, but not recruiting participants.
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: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Supplemental Vitamin D and Functional Outcomes in Early Adolescence

Resource links provided by NLM:


Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • 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: 3 weeks ] [ Designated as safety issue: Yes ]
  • fractional calcium absorption [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • fractional calcium absorption [ Time Frame: 9 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 323
Study Start Date: October 2009
Estimated Study Completion Date: July 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo tablet
Dietary Supplement: Vitamin D3
vitamin D3 supplementation at 400 IU vs 1,000 IU vs 4,000 IU vs 2,000 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 4,000 IU vs 2,000 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 4,000 IU vs 2,000 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 4,000 IU vs 2,000 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 4,000 IU vs 2,000 IU vs placebo for 12-weeks

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

Ages Eligible for Study:   9 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931580

Locations
United States, Georgia
The University of Georgia Dept of Foods & Nutrition
Athens, Georgia, United States, 30602
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
University of Georgia
Purdue University
Indiana University School of Medicine
Investigators
Principal Investigator: Richard D Lewis, PhD The University of Georgia
  More Information

No publications provided by University of Georgia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Richard D. Lewis, Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT00931580     History of Changes
Other Study ID Numbers: 1R01HD57126-01A2 UGA
Study First Received: July 1, 2009
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
Vitamin D
Adolescent
African American
White

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014