The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.
ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
207
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Children's Hopsital of Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.
Time frame: Baseline, Week 4, Week 12
To measure the safety of 50,000 IU dose of vitamin D3
Time frame: Baseline, Week 4, and Week 8
To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover
Time frame: Baseline, Week 4, and Week 12
To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover
Time frame: Baseline, Week 4, and Week 12
To measure the change in tenofovir exposure and creatinine clearance
Time frame: Baseline, Week 4, and Week 12
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Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Stroger Hospital of Cook County
Chicago, Illinois, United States
Childrens Memorial Hospital
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland Medical School
Baltimore, Maryland, United States
...and 5 more locations