N/A
N=52
Zinc Supplementation and Cardiovascular Risk in HIV
HIV · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT02856269 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) — 15; 15; 14; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zinc gluconate (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grace McComsey
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) |
15; 15; 14; 15; 12; 15 | — |
| SECONDARY Percentage of Participants That Reached the Zinc Sufficient Level After Treatment |
88; 96 | — |
Summary
The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.
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
Data sourced from ClinicalTrials.gov (NCT02856269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.