Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Study Details
Study Description
Brief Summary
To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Early Phase 1 |
Detailed Description
This study will focus on subjects with documented zinc deficiency (levels <75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Zinc gluconate Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. |
Drug: Zinc Gluconate
Two 45 mg capsules once daily
|
Placebo Comparator: Placebo Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. |
Drug: Placebo
Two placebo capsules once daily
|
Outcome Measures
Primary Outcome Measures
- Effect of zinc supplementation in HIV-infected subjects [baseline and 24 weeks]
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
- Effect of zinc supplementation in HIV-infected subjects [baseline and 24 Weeks]
Changes in markers of inflammation and immune activation by measuring momonocyte activation soluble markers CD14 (sCD14), high sensitivity C reactive protein (hsCRP), and soluble tumor necrosis alpha receptor I and II (sTNFR-I and II)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV-1 infection
-
Documentation of an HIV-1 RNA level of ≤400 copies/mL in the last 4 months prior to study entry
-
Male or Female age ≥18 years
-
Zinc level ≤0.75 mg/L in the last 60 days
Exclusion Criteria:
-
Pregnancy/lactation
-
Known cardiovascular disease
-
Uncontrolled diabetes
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- University Hospitals Cleveland Medical Center
- Case Western Reserve University
Investigators
- Principal Investigator: Grace A McComsey, MD, FIDSA, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Zinc study