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Vitamin D Needs of Early Adolescent Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Georgia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Purdue University
Indiana University School of Medicine
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00931580
First received: July 1, 2009
Last updated: July 21, 2010
Last verified: September 2009
History of Changes
  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:

MedlinePlus related topics: Calcium Vitamin D
U.S. FDA Resources

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 ]

Estimated Enrollment: 320
Study Start Date: October 2009
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931580

Contacts
Contact: Richard D Lewis, PhD 706-542-4901 rlewis@fcs.uga.edu

Locations
United States, Georgia
The University of Georgia Dept of Foods & Nutrition Recruiting
Athens, Georgia, United States, 30602
Contact: Richard D Lewis, PhD     706-542-4901     rlewis@fcs.uga.edu    
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Munro Peacock, MD     317-278-3446     mpeacock@iupui.edu    
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Connie Weaver, PhD     765-494-8231     weavercm@purdue.edu    
Principal Investigator: Connie Weaver, PhD            
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: Richard D Lewis - PI, The 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: July 21, 2010
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 May 16, 2013