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Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Primary Purpose

Inflammation, Cardiovascular Diseases, Zinc Deficiency

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zinc Gluconate
Placebo
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Zinc, inflammation, Cardiovascular Diseases risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc gluconate

Placebo

Arm Description

Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.

Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.

Outcomes

Primary Outcome Measures

Effect of zinc supplementation in HIV-infected subjects
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Effect of zinc supplementation in HIV-infected subjects
Changes in markers of inflammation and immune activation by measuring momonocyte activation soluble markers CD14 (sCD14), high sensitivity C reactive protein (hsCRP), and soluble tumor necrosis alpha receptor I and II (sTNFR-I and II)

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
June 28, 2023
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT05085834
Brief Title
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Official Title
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Cardiovascular Diseases, Zinc Deficiency
Keywords
Zinc, inflammation, Cardiovascular Diseases risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zinc gluconate
Arm Type
Experimental
Arm Description
Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Zinc Gluconate
Intervention Description
Two 45 mg capsules once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo capsules once daily
Primary Outcome Measure Information:
Title
Effect of zinc supplementation in HIV-infected subjects
Description
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Time Frame
baseline and 24 weeks
Title
Effect of zinc supplementation in HIV-infected subjects
Description
Changes in markers of inflammation and immune activation by measuring momonocyte activation soluble markers CD14 (sCD14), high sensitivity C reactive protein (hsCRP), and soluble tumor necrosis alpha receptor I and II (sTNFR-I and II)
Time Frame
baseline and 24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace A McComsey, MD, FIDSA
Phone
216-844-2739
Email
Grace.McComsey@UHhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Labbato, BSN
Phone
216-844-2739
Email
Danielle.Labbato@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace A McComsey, MD, FIDSA
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Zinc Effect on Inflammation and Cardiovascular Risk in HIV

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