Zinc Supplementation and Cardiovascular Risk in HIV

February 10, 2022 updated by: Grace McComsey
The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 45 mg daily
Participants in this arm will take a daily 45 mg dose of zinc gluconate.
Dietary supplement: Zinc gluconate
Participants will take a daily dose of zinc gluconate.
Active Comparator: 90 mg daily
Participants in this arm will take a daily 90 mg dose of zinc gluconate.
Dietary supplement: Zinc gluconate
Participants will take a daily dose of zinc gluconate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 16 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace McComsey

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

April 16, 2018

Study Completion (Actual)

April 16, 2018

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-15-07
  • 1R21AT009153-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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