Zinc Effect on Inflammation and Cardiovascular Risk in HIV
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects
研究概览
简要总结
To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy
详细描述
This study will focus on subjects with documented zinc deficiency (levels <75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, study staff, and the study statistician will be blinded to treatment allocation (zinc gluconate or placebo capsules). The research staff as well as the principle investigator will remain blinded to treatment assignment.
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
- •Documentation of an HIV-1 RNA level of ≤400 copies/mL in the last 4 months prior to study entry
- •Male or Female age ≥18 years
- •Zinc level ≤0.75 mg/L in the last 60 days
排除标准
- •Pregnancy/lactation
- •Known cardiovascular disease
- •Uncontrolled diabetes
研究组 & 干预措施
Placebo
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
干预措施: Placebo (Drug)
Zinc gluconate
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
干预措施: Zinc Gluconate (Drug)
结局指标
主要结局
Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects
时间窗: between baseline and 24 weeks
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
时间窗: between baseline and 24 Weeks
Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM)
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
时间窗: between baseline and 24 Weeks
Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10).
Effect of Zinc on oxLDL in HIV-infected Subjects
时间窗: between baseline and 24 Weeks
Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks
次要结局
- Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects(between baseline and 24 Weeks)
- Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects(between baseline and 24 Weeks)
研究者
Grace McComsey
Principal Investigator
University Hospitals Cleveland Medical Center