Zinc Supplementation and Cardiovascular Risk in HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
研究概览
简要总结
The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.
详细描述
Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •Age ≥18 years
- •Zinc level ≤0.75 mg/L
- •Receiving a stable antiretroviral regimen with no plans to change during study
- •Documentation of an HIV-1 RNA level of ≤400 copies/mL
- •No diarrhea or nausea/vomiting for the last month
排除标准
- •Pregnancy/lactation
- •Presence of inflammatory condition
- •Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
- •Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
- •Known cardiovascular disease
- •Uncontrolled diabetes
- •Allergy or intolerance to zinc sulfate.
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x Upper limit of normal (ULN)
- •Hemoglobin < 9.0 g/dL
- •glomerular filtration rate (GFR) < 50 mL/min
结局指标
主要结局
Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)
时间窗: Baseline and 16 Weeks
Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.
次要结局
- Percentage of Participants That Reached the Zinc Sufficient Level After Treatment(16 Weeks)
研究者
Grace McComsey
MD
University Hospitals Cleveland Medical Center