Zinc Supplementation and Cardiovascular Risk in HIV

Not Applicable

Completed

• Conditions: HIV; Inflammation
• Interventions: Dietary Supplement: Zinc gluconate

• Registration Number: NCT02856269
• Lead Sponsor: Grace McComsey

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.

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-04
• Study Start: 2016-09
• Primary Completion: 2018-04-16
• Study Completion: 2018-04-16
• Results First Submitted: 2020-08-18
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Results First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
90 mg daily	Zinc gluconate	Participants in this arm will take a daily 90 mg dose of zinc gluconate.
45 mg daily	Zinc gluconate	Participants in this arm will take a daily 45 mg dose of zinc gluconate.

Primary Outcome Measures

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

Name	Time	Method
Percentage of Participants That Reached the Zinc Sufficient Level After Treatment	16 Weeks	After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \>75 μg/dL.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States