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Zinc Supplementation and Cardiovascular Risk in HIV

G

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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