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Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05085834
Collaborator
Case Western Reserve University (Other)
93
Enrollment
1
Location
2
Arms
34.3
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

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
  • Drug: Zinc Gluconate
  • Drug: Placebo
 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

Study Type:
Interventional
Anticipated Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Patients, study staff, and the study statistician will be blinded to treatment allocation (zinc gluconate or placebo capsules). The research staff as well as the principle investigator will remain blinded to treatment assignment.
Primary Purpose:
Prevention
Official Title:
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Actual Study Start Date :
Jan 22, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

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

  1. 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

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Grace McComsey, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT05085834
Other Study ID Numbers:
  • Zinc study
First Posted:
Oct 20, 2021
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Grace McComsey, Principal Investigator, University Hospitals Cleveland Medical Center
Zinc
inflammation
Cardiovascular Diseases risk
Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation

Study Results

No Results Posted as of Jan 25, 2022