Zinc Supplementation and Cardiovascular Risk in HIV

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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HIV Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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

Study Groups

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45 mg daily

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

Group Type ACTIVE_COMPARATOR

Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Participants will take a daily dose of zinc gluconate.

90 mg daily

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

Group Type ACTIVE_COMPARATOR

Zinc gluconate

Intervention Type DIETARY_SUPPLEMENT

Participants will take a daily dose of zinc gluconate.

Interventions

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Zinc gluconate

Participants will take a daily dose of zinc gluconate.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No