ATN 063_CRF 11 Study Agent Pre-Administration Dataset in Randomized, Placebo-Controlled Trial of Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in HIV-infected Adolescents and Young Adults Treated with ART Containing Tenofovir

Data from Study Agent Pre-Administration Checklist [CRF 11]
Study Description
This study was a randomized, double-blind, placebo-controlled prospective study. The study tested 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. A randomized, placebo-controlled trial was conducted over 12 weeks, with four arms: those who received tenofovir and vitamin D, those who received tenofovir and no vitamin D, those who received vitamin D and no tenofovir, and those who received neither tenofovir nor vitamin D.
HIV-1 infected males and females, ages 18 to 24