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Completed

NCT Number: NCT02856269

Zinc Supplementation and Cardiovascular Risk in HIV

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

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Key information

Conditions

HIV Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Zinc gluconate

Dietary Supplement

Participants will take a daily dose of zinc gluconate.

Primary outcomes

  1. Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants That Reached the Zinc Sufficient Level After Treatment

    Time frame: 16 Weeks

    After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels >75 μg/dL.

Sponsors and collaborators

Lead sponsor

Grace McComsey

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Feb 11, 2022

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.

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