Zinc Supplementation and Cardiovascular Risk in HIV

Grace McComsey

Status: Completed

Conditions: Inflammation; HIV

Treatments: Dietary Supplement: Zinc gluconate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02856269

1R21AT009153-01 (U.S. NIH Grant/Contract)

02-15-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

45 mg daily

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc gluconate

90 mg daily

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc gluconate