Zinc Effect on Inflammation and Cardiovascular Risk in HIV

University Hospitals (UH)

Status and phase: Completed; Early Phase 1

Conditions: Inflammation; Cardiovascular Diseases; Zinc Deficiency

Treatments: Drug: Zinc Gluconate; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05085834

Zinc study

1R21AT009153 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Zinc gluconate

Experimental group

Description:

Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.

Treatment:

Drug: Zinc Gluconate

Placebo

Placebo Comparator group

Description:

Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.

Treatment:

Drug: Placebo