InflammationEarly Phase 1NCT05085834

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

A Early Phase 1 study testing Zinc Gluconate in people with Inflammation and Cardiovascular Diseases, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammation, Cardiovascular Diseases, Zinc Deficiency
What is being tested?: Zinc Gluconate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2020to 2 Aug 2024
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnancy/lactation
Known cardiovascular disease
Uncontrolled diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

Read the 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
Being tested: Zinc Gluconate, Placebo
Keywords: Zinc, inflammation, Cardiovascular Diseases risk
Medical subject headings: Inflammation, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zinc GluconateDrug
Two 45 mg capsules once daily
PlaceboDrug
Two placebo capsules once daily

Study groups in NCT05085834
Study group	Role	What they receive
Zinc gluconate	Experimental	Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. Receives: Drug: Zinc Gluconate
Placebo	Placebo comparator	Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: 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).
Measured: 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
Measured: between baseline and 24 Weeks

Secondary outcomes (10)

Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides.
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio
Measured: between baseline and 24 Weeks
the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)
Measured: between baseline and 24 Weeks
Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-
Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects
Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects
Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia.
A Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function.
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects
Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG)
Measured: between baseline and 24 Weeks
Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects
Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.
Measured: between baseline and 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 20202 Aug 2024

First posted20 Oct 2021
Study start22 Jan 2020
Primary completion2 Aug 2024
Study completion2 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05085834
Sponsor's protocol ID: Zinc study
Other IDs: 1R21AT009153
Status last verified: Jun 2025
First submitted: 2 Jul 2019
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zinc Effect on Inflammation and Cardiovascular Risk in HIV
ClinicalTrials.gov ID: NCT05085834
Acronym / sponsor ID: Zinc study
Conditions: Inflammation, Cardiovascular Diseases, Zinc Deficiency
Keywords: Zinc, inflammation, Cardiovascular Diseases risk
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: Case Western Reserve University, National Center for Complementary and Integrative Health (NCCIH)
Study start: 22 Jan 2020 (actual)
Primary completion: 2 Aug 2024 (actual)
Study completion: 2 Aug 2024 (actual)
First posted: 20 Oct 2021 (actual)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Zinc gluconate	Experimental	Drug: Zinc GluconatePatients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.
Placebo	Placebo comparator	Drug: PlaceboPatients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Pregnancy/lactation
Known cardiovascular disease
Uncontrolled diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zinc GluconateTwo 45 mg capsules once daily	Drug	Zinc gluconate
PlaceboTwo placebo capsules once daily	Drug	Placebo

Primary outcome

Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 weeks
Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency
Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
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)
Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
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).
Effect of Zinc on oxLDL in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks

10 secondary outcomes

Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects
Time frame: between baseline and 24 Weeks
Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects
Time frame: between baseline and 24 Weeks

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zinc Gluconate	63	47
Placebo	32	29

Primary outcome: Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects

Time frame: between baseline and 24 weeks. Median (Inter-Quartile Range). Unit: absolute change (μg/dL)

Measure	Placebo n = 32	Zinc 90 mg n = 63
Value	8.60 (1.65 to 20.00)	33.50 (14.00 to 62.70)

Placebo vs Zinc 90 mg: β coefficient: 0.71 (95% CI 0.43 to 0.98), p <0.01, linear combination of coefficients

Population analysed: absolute changes for outcome measures over 24 weeks for each group

Primary outcome: Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects

Time frame: between baseline and 24 Weeks. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Placebo n = 32	Zinc 90 mg n = 63
hsCRP (ng/mL)	-22.86 (-689.27 to 1744.48)	1.33 (-602.56 to 1174.87)
sCD14 (ng/mL)	101.71 (-90.50 to 243.20)	-56.31 (-263.24 to 134.19)
sCD163 (ng/mL)	-50.11 (-153.06 to 89.80)	43.69 (-102.27 to 126.91)
D-dimer (ng/mL)	-149.05 (-294.46 to 58.72)	-45.85 (-295.57 to 142.43)
VCAM (ng/mL)	66.69 (-2.65 to 187.38)	49.53 (-55.61 to 170.15)
ICAM (ng/mL)	-2.03 (-28.37 to 22.30)	2.35 (-29.19 to 42.46)

Placebo vs Zinc 90 mg: β coefficient: -0.002 (95% CI -0.57 to 0.57), p = 1.00, linear combination of coefficients
Placebo vs Zinc 90 mg: β coefficient: -0.08 (95% CI -0.18 to 0.01), p = 0.08, linear combination of coefficients
Placebo vs Zinc 90 mg: β coefficient: -0.03 (95% CI -0.21 to 0.15), p = 0.77, linear combination of coefficients

Population analysed: absolute changes for outcome measures over 24 weeks for each group

Primary outcome: Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects

Time frame: between baseline and 24 Weeks. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Placebo n = 32	Zinc 90 mg n = 63
sTNF-RI (pg/mL)	-25.08 (-209.51 to 186.66)	1.27 (-236.80 to 168.27)
sTNF-RII (pg/mL)	-121.65 (-457.93 to 467.29)	99.33 (-484.31 to 477.72)
IL-6 (pg/mL)	-0.47 (-0.85 to 0.61)	-0.02 (-0.88 to 0.72)
IP-10 (pg/mL)	0.23 (-44.28 to 29.08)	-9.99 (-31.65 to 20.27)

Placebo vs Zinc 90 mg: β coefficient: 0.04 (95% CI -0.09 to 0.16), p = 0.55, linear combination of coefficients
Placebo vs Zinc 90 mg: β coefficient: -0.004 (95% CI -0.13 to 0.13), p = 0.95, linear combination of coefficients
Placebo vs Zinc 90 mg: β coefficient: 0.07 (95% CI -0.30 to 0.43), p = 0.73, linear combination of coefficients

Population analysed: absolute changes for outcome measures over 24 weeks for each group

Primary outcome: Effect of Zinc on oxLDL in HIV-infected Subjects

Time frame: between baseline and 24 Weeks. Median (Inter-Quartile Range). Unit: U/L

Measure	Placebo n = 32	Zinc 90 mg n = 63
Value	20833.33 (2397.72 to 61644.46)	8639.79 (-1716.35 to 43693.14)

Placebo vs Zinc 90 mg: β coefficient: 1819.18 (95% CI -14899.37 to 18537.74), p = 0.83, linear combination of coefficients

Population analysed: absolute changes for outcome measures over 24 weeks for each group

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zinc Gluconate	1 of 63 (1.6%)	48 of 63 (76.2%)	1 of 63
Placebo	0 of 32 (0%)	27 of 32 (84.4%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grace A McComsey, MD, FIDSA principal investigator

University Hospitals Cleveland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Zinc Gluconate in people with Inflammation and Cardiovascular Diseases, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects (time frame: between baseline and 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.