Zinc Effect on Inflammation and Cardiovascular Risk in HIV
- Conditions
- InflammationZinc DeficiencyCardiovascular Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05085834
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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
- Pregnancy/lactation
- Known cardiovascular disease
- Uncontrolled diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Zinc gluconate Zinc Gluconate Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
- Primary Outcome Measures
Name Time Method Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects 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 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 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 between baseline and 24 Weeks Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks
- Secondary Outcome Measures
Name Time Method Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides.
Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio
the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)
Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)
Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV- between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)
Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects between baseline and 24 Weeks Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome
Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects between baseline and 24 Weeks Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG)
Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects between baseline and 24 Weeks Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia.
A Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function.Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects between baseline and 24 Weeks Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center🇺🇸Cleveland, Ohio, United States