Optimizing Vitamin D Treatment in HIV/AIDS: An RCT

优化 HIV/艾滋病维生素 D 治疗：随机对照试验

• 批准号: 8285165
• 负责人: Andrea D. Branch
• 金额: $ 65.98万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8285165
• 关键词: 25-hydroxyvitamin D; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Adverse effects; Anti-Inflammatory Agents; Anti-inflammatory; Antiviral Agents; Bone Density; CD4 Positive T Lymphocytes; Calcium; Caring; Caucasians; Caucasoid Race; Cell Count; Cells; Cholecalciferol; Chronic; Clinical; Clinical Trials; Counseling; Cross-Sectional Studies; Data; Disease Marker; Dose; Double-Blind Method; Enrollment; European; Event; Expert Opinion; Fatigue; Future; Goals; Guidelines; HIV; HIV Seropositivity; Health; Health Benefit; Highly Active Antiretroviral Therapy; Hormones; Hypercalcemia; Immune; Immune response; Immune system; Individual; Inflammation; Kidney Calculi; Longevity; Longitudinal Studies; Maintenance; Measures; Medical; Mental Depression; Metabolic Diseases; Monitor; Multicenter Trials; Online Systems; Oral; Outcome Measure; Parathyroid gland; Patient Self-Report; Patients; Pharmaceutical Preparations; Physicians; Protocols documentation; Provider; Publishing; Randomized; Randomized Controlled Trials; Recommendation; Regimen; Reporting; Risk; Rosa; Safety; Societies; Source; System; T-Lymphocyte Subsets; Tenofovir; Testing; Titrations; Treatment Protocols; Viral Load result; Vitamin D; Vitamin D Deficiency; Vitamin D2; arm; base; bone; bone metabolism; calcium intake; calcium metabolism; cardiovascular disorder risk; cardiovascular risk factor; clinically significant; comparative effectiveness; design; effectiveness measure; evidence base; evidence based guidelines; experience; global health; head-to-head comparison; inflammatory marker; primary outcome; psychologic; reconstitution; response; secondary outcome; time interval; trial comparing

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.

在哈特后时代，患者继续遭受医疗的不利影响 艾滋病毒/艾滋病。不良影响包括不完全的免疫重建，慢性炎症， 抑郁症，心血管和代谢疾病的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，减少 如果服用适当的剂量，炎症，减轻抑郁症并增加寿命。到 获得最大的好处，大多数维生素D专家都同意维生素D治疗应提高 高于30 ng/ml的25-羟基维生素D [25（OH）D]的浓度。越来越多的艾滋病毒 护理提供者希望一项基于证据的协议来达到这25（OH）D目标水平。 该项目解决了对治疗HIV中维生素D缺乏症的经过验证的方案的需求 哈特的积极个人。目标我的目的是进行12毫可随机的，双重的 盲试验比较患者口服维生素D加0.5 g/d的两种给药方案 在稳定的HAART上，有25（OH）D级别25 ng/ml和无法检测到的HIV病毒负荷 基线（每臂100）。用药事件监控系统（MEMS）帽将用于 记录补充使用并促进依从性。协议A中的受试者将获得50,000 维生素D2的IU/wk，用于8周，然后是1000 IU/d的维生素D3，适用于48周。协议中的主题 B将获得2000-4000 IU/D的维生素D3，具体取决于基底25（OH）D水平 必要时根据初始响应的斜率滴定。主要结果 测量是25（OH）D水平在30-的受试者百分比的差异 12 mo时60 ng/ml。次要结果是25（OH）D响应曲线的斜率 各种时间间隔。 AIM II的目的是比较两个协议对 疾病标记。主要结果度量是CD4+T细胞计数的变化。 次要结果包括CD4+ T细胞子集的变化，炎症标记，标记 骨骼和钙代谢，自我报告的心理状况，病毒负荷，副作用， 安全和依从性。据我们所知，这项试验是第一个面对面的比较 使用一定剂量的维生素D2与使用分层起始剂量的方案的方案 维生素D3。该项目将产生验证的方案，用于治疗HIV中的维生素D缺乏症 在HAART上感染了患者，并将提供有关风险和健康益处的初始数据 维生素D和钙补充剂。此信息对于设计确定性至关重要 将来的多中心试验。