Optimizing Vitamin D Treatment in HIV/AIDS: An RCT

在后HAART时代，患者继续遭受HAART的不良医疗后果。 艾滋病毒/艾滋病的不良反应包括免疫重建不完全，慢性炎症， 抑郁症、心血管和代谢疾病风险增加以及骨密度低。 临床试验表明，维生素D补充剂可以增加骨密度， 炎症，减轻抑郁症，并增加寿命，如果给予足够的剂量。到 大多数维生素D专家认为，维生素D治疗应该提高 25-羟基维生素D [25（OH）D]的浓度高于30 ng/ml。越来越多的艾滋病毒 护理提供者希望基于证据的方案来达到这些25（OH）D目标水平。 该项目解决了需要一个有效的协议，治疗维生素D缺乏症的艾滋病毒- 对HAART有积极作用的人。目的I的目标是进行一项12个月的随机化、双- 在患者中比较两种口服维生素D加0.5 g/d钙给药方案的盲法试验 25（OH）D水平25 ng/ml且HIV病毒载量检测不到的稳定HAART患者， 基线（每组100例）。药物事件监测系统（MEMS）帽将用于 记录补充剂的使用并促进依从性。方案A中的受试者将接受50，000 维生素D2 8 wk，随后维生素D3 1000 IU/d，48 wk。方案中的受试者 B将接受2000-4000 IU/d的维生素D3，取决于基础25（OH）D水平，剂量 必要时，根据初始响应的斜率进行滴定。主要结局 测量是25（OH）D水平在30- 100范围内的受试者百分比的差异。 12个月时60 ng/ml。次要结果是25（OH）D反应曲线的斜率， 不同的时间间隔。目标二的目标是比较两个协议对 疾病的标志。主要结果指标是CD 4 +T细胞计数的变化。 次要结果包括CD 4 + T细胞亚群、炎症标志物、标志物 骨和钙代谢，自我报告的心理状态，病毒载量，副作用， 安全和坚持。据我们所知，这项试验是第一次头对头的比较， 使用负荷剂量的维生素D2的方案与使用分层起始剂量的维生素D2的方案 维生素D3。该项目将产生一个有效的治疗艾滋病毒维生素D缺乏症的方案， 感染的患者进行HAART，并将提供有关风险和健康益处的初步数据， 维生素D和钙补充剂这些信息对于设计明确的 多中心临床试验。

In the post-HAART era, patients continue to suffer from the adverse medical consequences of HIV/AIDS. The adverse effects include incomplete immune reconstitution, chronic inflammation, depression, increased risk of cardiovascular and metabolic disease, and low bone density. Clinical trials suggest that vitamin D supplements can increase bone density, reduce inflammation, alleviate depression, and increase longevity if given in adequate doses. To achieve maximum benefits, most vitamin D experts agree that vitamin D treatments should raise the concentration of 25-hydroxyvitamin D [25(OH)D] above 30 ng/ml. A growing number of HIV care providers desire an evidence-based protocol for achieving these 25(OH)D target levels. This project addresses the need for a validated protocol for treating vitamin D deficiency in HIV- positive individuals on HAART. The goal of Aim I is to conduct a 12-mo randomized, double- blinded trial comparing two dosing regimens of oral vitamin D plus 0.5 g/d of calcium in patients on stable HAART who have 25(OH)D levels 25 ng/ml and undetectable HIV viral load at baseline (100 per arm). Medication event monitoring system (MEMS) caps will be used to record supplement use and to promote adherence. Subjects in Protocol A will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk. Subjects in Protocol B will receive 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response. The primary outcome measure is the difference in the percentage of subjects with 25(OH)D levels in the range of 30- 60 ng/ml at 12 mo. The secondary outcome is the slope of the 25(OH)D response curve during various time intervals. The goal of Aim II is to compare the impact of the two protocols on markers of disease. The primary outcome measure is the change in the CD4+T cell count. Secondary outcomes include changes in CD4+ T cell subsets, markers of inflammation, markers of bone and calcium metabolism, self-reported psychological status, viral load, side effects, safety, and adherence. To our knowledge, this trial is the first head-to-head comparison of a regimen that uses a loading dose of vitamin D2 with a regimen that uses a tiered starting dose of vitamin D3. The project will yield a validated protocol for treating vitamin D deficiency in HIV- infected patients on HAART and will provide initial data about the risks and health benefits of vitamin D and calcium supplements. This information is essential for designing definitive multicenter trials in the future.