ATN 063_CRF 15 Form Number 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 Data Explanation Form: Form Number [CRF 15]
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

数据说明表来源：表格编号[CRF 15]
研究概况
本研究为一项随机、双盲、安慰剂对照的前瞻性研究，旨在验证以下假说：在接受替诺福韦（tenofovir）作为抗逆转录病毒（antiretroviral, ARV）联合治疗方案一部分的HIV感染青少年及年轻成人人群中，补充维生素D可减少肾脏磷酸盐丢失、升高血浆磷酸盐水平、降低血浆甲状旁腺激素（Parathyroid Hormone, PTH），并改善骨转换标志物水平，包括降低血浆N端肽（N-telopeptide）与骨特异性碱性磷酸酶（Bone-specific Alkaline Phosphatase, BAP）。
本研究为期12周，采用随机安慰剂对照试验设计，共设置4个干预组：接受替诺福韦联合维生素D治疗组、仅接受替诺福韦组、仅补充维生素D组，以及既未使用替诺福韦也未补充维生素D的对照组。
研究对象为18至24岁的HIV-1感染男性及女性受试者。