Vitamin D3 Supplementation Pilot Study
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether taking vitamin D, every day, over
      a 12 week period will improve the vitamin D status, risks for poor heart health, risks for
      developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers
      with low vitamin D levels.
    

Detailed description: 
      Vitamin D deficiency/insufficiency is common throughout the lifespan, and across all race and
      ethnic groups. The American Academy of Pediatrics (AAP) recently recommended supplementation
      dose to 400 international units (IU) daily in all children. These recommendations target
      rickets prevention, but address neither the vitamin D supplementation necessary to optimize
      bone health nor the nontraditional vitamin D roles in immune disease, insulin resistance,
      muscle function, and cardiovascular disease (CVD). Moreover, the AAP recommendation noted
      that it had little pediatric data upon which to base guidelines. The Institute of Medicine
      also recently published Dietary Reference Intakes for Calcium and Vitamin D: the estimated
      average requirement in children and adults was set at 400(IU) daily and the recommend dietary
      allowance was set at 600 IU daily. Data on outcomes and supplementation levels in African
      Americans (a population at particular risk for vitamin D deficiency) and across pediatric age
      ranges and body habitus types, are lacking. The Vitamin D supplementation requirement in
      obese, African American adolescents is particularly problematic since obesity is associated
      with 1) lower circulating vitamin D levels (25OHD) and 2) insulin resistance. This pilot
      study will examine the effect of vitamin D supplementation upon 25OHD, the serum marker of
      vitamin D status, in obese, African American adolescents with vitamin D deficiency. Subjects
      will be randomized to receive cholecalciferol 1000 IU or 5000 IU daily for 3 months. Serum
      25OHD, parathyroid hormone, glucose, insulin, CVD risk markers, and measures of muscle
      function and pain will be obtained at baseline and post-treatment. This pilot study will
      provide data on serum 25OHD responses to vitamin D at doses more likely to meaningfully
      impact 25OHD than the current American Academy of Pediatrics (AAP) supplementation guideline.
      Responses to supplementation can then inform future clinical trials aimed at addressing
      outcomes of vitamin D replacement on insulin sensitivity and CVD risk in obese adolescents.
    

Intervention name(s): Cholecalciferol; Cholecalciferol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 IU by mouth, once daily for 3 months.; 5000 IU by mouth, once daily for 3 months.
Other intervention name(s): Vitamin D; Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D deficiency