NCT05085834

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Inflammation
• Cardiovascular Diseases
• Zinc Deficiency

Interventions

Type	Name	Description
DRUG	Zinc Gluconate	Two 45 mg capsules once daily
DRUG	Placebo	Two placebo capsules once daily

Timeline

• Start date: 2020-01-22
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2021-10-20
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study