ATN 063 USDA Lab Visit 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

USDA lab visit data collected from external sources
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

从外部来源采集的美国农业部（USDA）实验室到访数据
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。本研究旨在验证下述假说：在以替诺福韦作为抗逆转录病毒（ARV）联合治疗方案组成部分的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（PTH）水平，并改善骨转换标志物指标，具体包括降低血浆N-端肽（N-telopeptide）及骨碱性磷酸酶（BAP）水平。本研究开展了一项为期12周的随机安慰剂对照试验，共设置4个试验组：接受替诺福韦与维生素D组、接受替诺福韦但未补充维生素D组、补充维生素D但未使用替诺福韦组，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。