Zinc Effect on Inflammation and Cardiovascular Risk in HIV

NCT05085834 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: Zinc study1R21AT009153
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammation; Cardiovascular Diseases; Zinc Deficiency

Keywords

Zinc; inflammation; Cardiovascular Diseases risk

Outcome Measures

Primary Outcomes (4)

• Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects

  Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency

  between baseline and 24 weeks

• Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects

  Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM)

  between baseline and 24 Weeks

• Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects

  Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10).

  between baseline and 24 Weeks

• Effect of Zinc on oxLDL in HIV-infected Subjects

  Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks

  between baseline and 24 Weeks

Secondary Outcomes (10)

• Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects

  between baseline and 24 Weeks

• Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects

  between baseline and 24 Weeks

• the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects

  between baseline and 24 Weeks

• Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects

  between baseline and 24 Weeks

• Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects

  between baseline and 24 Weeks

Study Arms (2)

Zinc gluconate

EXPERIMENTAL

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

Drug: Zinc Gluconate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zinc Gluconate DRUG

Two 45 mg capsules once daily

Zinc gluconate

Placebo DRUG

Two placebo capsules once daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy/lactation
• Known cardiovascular disease
• Uncontrolled diabetes

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Inflammation; Cardiovascular Diseases

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Grace McComsey
• Organization: University Hospitals Cleveland Medical Center

Grace.McComsey@uhhospitals.org

216-368-3731

Study Officials

• Grace A McComsey, MD, FIDSA

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: October 20, 2021
• Study Start: January 22, 2020
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Locations

US (1)