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Zinc Supplementation and Cardiovascular Risk in HIV

Primary Purpose

HIV, Inflammation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Zinc gluconate

About this trial

This is an interventional supportive care trial for HIV focused on measuring Zinc

Eligibility Criteria

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

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

Sites / Locations

University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

45 mg daily

90 mg daily

Arm Description

Participants in this arm will take a daily 45 mg dose of zinc gluconate.

Participants in this arm will take a daily 90 mg dose of zinc gluconate.

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

Percentage of Participants That Reached the Zinc Sufficient Level After Treatment

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

Full Information

NCT ID

NCT02856269

First Posted

July 29, 2016

Last Updated

February 10, 2022

Sponsor

Grace McComsey

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT02856269

Brief Title

Zinc Supplementation and Cardiovascular Risk in HIV

Official Title

Zinc Supplementation and Cardiovascular Risk in HIV

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

April 16, 2018 (Actual)

Study Completion Date

April 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Grace McComsey

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Inflammation

Keywords

Zinc

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.

Masking

InvestigatorOutcomes Assessor

Masking Description

Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

45 mg daily

Arm Type

Active Comparator

Arm Description

Participants in this arm will take a daily 45 mg dose of zinc gluconate.

Arm Title

90 mg daily

Arm Type

Active Comparator

Arm Description

Participants in this arm will take a daily 90 mg dose of zinc gluconate.

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc gluconate

Intervention Description

Participants will take a daily dose of zinc gluconate.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and 16 Weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants That Reached the Zinc Sufficient Level After Treatment

Description

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

Time Frame

16 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grace McComsey, MD

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

12. IPD Sharing Statement

Plan to Share IPD

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Zinc Supplementation and Cardiovascular Risk in HIV

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