HIV Clinical Trial
Official title:
Zinc Supplementation and Cardiovascular Risk in HIV
Verified date | February 2022 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.
Status | Completed |
Enrollment | 52 |
Est. completion date | April 16, 2018 |
Est. primary completion date | April 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Grace McComsey | National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP) | 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. | Baseline and 16 Weeks | |
Secondary | Percentage of Participants That Reached the Zinc Sufficient Level After Treatment | After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels >75 µg/dL. | 16 Weeks |
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