Skip to main content
OpenTrials
Completed

NCT Number: NCT05085834

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Zinc Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy/lactation
  • Known cardiovascular disease
  • Uncontrolled diabetes

Treatment and study plan

Zinc gluconate

Drug

Two 45 mg capsules once daily

Placebo

Drug

Two placebo capsules once daily

Primary outcomes

  1. Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects

    Time frame: between baseline and 24 weeks

    Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency

  2. Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects

    Time frame: 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)

  3. Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects

    Time frame: 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).

  4. Effect of Zinc on oxLDL in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks

Secondary outcomes

  1. Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects

    Time frame: 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.

  2. Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio

  3. the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)

  4. Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)

  5. Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)

  6. Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-

    Time frame: between baseline and 24 Weeks

    Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)

  7. Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects

    Time frame: 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

  8. Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects

    Time frame: 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.

  9. Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects

    Time frame: 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)

  10. Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects

    Time frame: between baseline and 24 Weeks

    Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Case Western Reserve University
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2021
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.