N/A Completed N=52 Randomized Double-blind Supportive Care

Zinc Supplementation and Cardiovascular Risk in HIV

Source: ClinicalTrials.gov NCT02856269 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2022

Primary outcomePrimary: Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) — 15; 15; 14; 15 Participants

Summary

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

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.