An interventional study of Cholecalciferol and Cholecalciferol in Vitamin D Deficiency, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-23.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 39 is below the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Cholecalciferol
Dietary Supplement: Cholecalciferol
1000 IU by mouth, once daily for 3 months.
Also known as: Vitamin D
5000 IU by mouth, once daily for 3 months.
Also known as: Vitamin D
Serum 25OHD before and after treatment
The analysis will be an intention-to-treat method in which subjects are assumed to obtain all vitamin D supplements from the study and from no other sources, and all subjects are assumed to comply with their assigned dose and daily use. For the main contrasts of interest (5000 IU vs 1000 IU doses as well as serum 25OHD concentrations), we propose a longitudinal mixed effects model with time measurements at 0 and 12 weeks.
Time frame: 12 weeks
Adiponectin level comparison
Adiponectin level comparison before and at post-treatment
Time frame: 12 weeks
Lipid panel comparison
Lipid panel comparison before and at post-treatment
Time frame: 12 weeks
Lipoprotein subclass particles comparison
Lipoprotein subclass particles comparison before and at post-treatment
Time frame: 12 weeks
High-sensitivity C-Reactive Protein (hsCRP) comparison
High-sensitivity C-Reactive Protein (hsCRP) comparison before and at post-treatment
Time frame: 12 weeks
Insulin level comparison
Insulin level comparison before and at post-treatment
Time frame: 12 weeks
Total and undercarboxylated osteocalcin level comparison
Total and undercarboxylated osteocalcin level comparison before and at post-treatment
Time frame: 12 weeks
Muscle strength comparison
Muscle strength comparison before and at post-treatment
Time frame: 12 weeks
Musculoskeletal pain comparison
Musculoskeletal pain comparison before and at post-treatment
Time frame: 12 weeks
Blood pressure comparison
Blood pressure comparison before and at post-treatment
Time frame: 12 weeks
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia