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Vitamin D Needs of Early Adolescent Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00931580
First Posted: July 2, 2009
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Purdue University
Indiana University School of Medicine
Information provided by (Responsible Party):
Dr. Richard D. Lewis, University of Georgia
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Dr. Richard D. Lewis, University of Georgia:

Primary Outcome Measures:
  • serum 25(OH)D [ Time Frame: 0 weeks ]
  • PTH [ Time Frame: 0 weeks ]
  • 1,25(OH)2D [ Time Frame: 0 weeks ]
  • fractional calcium absorption [ Time Frame: 0 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 0 weeks ]
  • serum 25(OH)D [ Time Frame: 3 weeks ]
  • serum 25(OH)D [ Time Frame: 6 weeks ]
  • serum 25(OH)D [ Time Frame: 9 weeks ]
  • serum 25(OH)D [ Time Frame: 12 weeks ]
  • PTH [ Time Frame: 3 weeks ]
  • PTH [ Time Frame: 6 weeks ]
  • PTH [ Time Frame: 9 weeks ]
  • PTH [ Time Frame: 12 weeks ]
  • 1,25(OH)2D [ Time Frame: 3 weeks ]
  • 1,25(OH)2D [ Time Frame: 6 weeks ]
  • 1,25(OH)2D [ Time Frame: 9 weeks ]
  • 1,25(OH)2D [ Time Frame: 12 weeks ]
  • fractional calcium absorption [ Time Frame: 12 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 3 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 6 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 9 weeks ]
  • biochemical markers of bone turnover [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • sunlight exposure [ Time Frame: 0 weeks ]
  • dietary data [ Time Frame: 0 weeks ]
  • physical activity data [ Time Frame: 0 weeks ]
  • serum and urinary calcium [ Time Frame: 0 weeks ]
  • body composition [ Time Frame: 0 weeks ]
  • sunlight exposure [ Time Frame: 3 weeks ]
  • sunlight exposure [ Time Frame: 6 weeks ]
  • sunlight exposure [ Time Frame: 9 weeks ]
  • sunlight exposure [ Time Frame: 12 weeks ]
  • dietary data [ Time Frame: 3 weeks ]
  • dietary data [ Time Frame: 6 weeks ]
  • dietary data [ Time Frame: 9 weeks ]
  • dietary data [ Time Frame: 12 weeks ]
  • physical activity data [ Time Frame: 3 weeks ]
  • physical activity data [ Time Frame: 6 weeks ]
  • physical activity data [ Time Frame: 9 weeks ]
  • physical activity data [ Time Frame: 12 weeks ]
  • serum and urinary calcium [ Time Frame: 3 weeks ]
  • serum and urinary calcium [ Time Frame: 6 weeks ]
  • serum and urinary calcium [ Time Frame: 9 weeks ]
  • serum and urinary calcium [ Time Frame: 12 weeks ]
  • body composition [ Time Frame: 3 weeks ]
  • body composition [ Time Frame: 6 weeks ]
  • body composition [ Time Frame: 9 weeks ]
  • body composition [ Time Frame: 12 weeks ]

Enrollment: 323
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 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 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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Submitted: July 1, 2009
First Posted: July 2, 2009
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by Dr. Richard D. Lewis, University of Georgia:
Vitamin D
Adolescent
African American
White

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