NCT05085834

Zinc Effect on Inflammation and Cardiovascular Risk in HIV

Completed EARLY_PHASE1 Results posted Last updated 12 June 2025

What this trial tests

EARLY_PHASE1 trial testing Zinc Gluconate in Inflammation in 95 participants. Completed in 2 August 2024.

Timeline

22 January 2020

Primary endpoint
2 August 2024

2 August 2024

Quick facts

Lead sponsor	University Hospitals Cleveland Medical Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	95
Start date	22 January 2020
Primary completion	2 August 2024
Estimated completion	2 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Zinc Gluconate — full drug profile →
• Placebo

Conditions studied

• Inflammation — all drugs for Inflammation →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Zinc Deficiency — all drugs for Zinc Deficiency →

Sponsor

University Hospitals Cleveland Medical Center

Who can join

18 and older, any sex, with Inflammation or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects Primary · between baseline and 24 weeks

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

Group	Value	95% CI
Placebo	8.60	1.65 – 20.00
Zinc 90 mg	33.50	14.00 – 62.70

Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects Primary · 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)

hsCRP (ng/mL)

Group	Value	95% CI
Placebo	-22.86	-689.27 – 1744.48
Zinc 90 mg	1.33	-602.56 – 1174.87

sCD14 (ng/mL)

Group	Value	95% CI
Placebo	101.71	-90.50 – 243.20
Zinc 90 mg	-56.31	-263.24 – 134.19

sCD163 (ng/mL)

Group	Value	95% CI
Placebo	-50.11	-153.06 – 89.80
Zinc 90 mg	43.69	-102.27 – 126.91

D-dimer (ng/mL)

Group	Value	95% CI
Placebo	-149.05	-294.46 – 58.72
Zinc 90 mg	-45.85	-295.57 – 142.43

VCAM (ng/mL)

Group	Value	95% CI
Placebo	66.69	-2.65 – 187.38
Zinc 90 mg	49.53	-55.61 – 170.15

ICAM (ng/mL)

Group	Value	95% CI
Placebo	-2.03	-28.37 – 22.30
Zinc 90 mg	2.35	-29.19 – 42.46

Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects Primary · 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).

sTNF-RI (pg/mL)

Group	Value	95% CI
Placebo	-25.08	-209.51 – 186.66
Zinc 90 mg	1.27	-236.80 – 168.27

sTNF-RII (pg/mL)

Group	Value	95% CI
Placebo	-121.65	-457.93 – 467.29
Zinc 90 mg	99.33	-484.31 – 477.72

IL-6 (pg/mL)

Group	Value	95% CI
Placebo	-0.47	-0.85 – 0.61
Zinc 90 mg	-0.02	-0.88 – 0.72

IP-10 (pg/mL)

Group	Value	95% CI
Placebo	0.23	-44.28 – 29.08
Zinc 90 mg	-9.99	-31.65 – 20.27

Effect of Zinc on oxLDL in HIV-infected Subjects Primary · between baseline and 24 Weeks

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

Group	Value	95% CI
Placebo	20833.33	2397.72 – 61644.46
Zinc 90 mg	8639.79	-1716.35 – 43693.14

Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

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.

Non-HDL cholesterol (mg/dL)

Group	Value	95% CI
Placebo	3.10	-28.20 – 26.50
Zinc 90 mg	1.35	-12.30 – 10.85

HDL (mg/dL)

Group	Value	95% CI
Placebo	-1.70	-4.60 – 1.40
Zinc 90 mg	-2.45	-8.45 – 1.25

LDL (mg/dL)

Group	Value	95% CI
Placebo	6.00	-28.00 – 16.00
Zinc 90 mg	-1.50	-19.50 – 11.50

VLDL (mg/dL)

Group	Value	95% CI
Placebo	0.50	-6.00 – 3.50
Zinc 90 mg	2.00	-2.00 – 6.00

Cholesterol (mg/dL)

Group	Value	95% CI
Placebo	2.00	-25.00 – 27.00
Zinc 90 mg	-3.50	-23.50 – 12.00

Triglycerides (mg/dL)

Group	Value	95% CI
Placebo	2.00	-29.00 – 12.00
Zinc 90 mg	7.00	-12.50 – 34.50

Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio

Group	Value	95% CI
Placebo	0.10	-0.20 – 0.40
Zinc 90 mg	0.10	-0.10 – 0.45

the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)

Group	Value	95% CI
Placebo	0.28	-0.52 – 1.16
Zinc 90 mg	0.10	-0.58 – 0.95

Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)

Group	Value	95% CI
Placebo	0.50	-2.53 – 2.50
Zinc 90 mg	1.67	-2.67 – 3.00

Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)

Group	Value	95% CI
Placebo	2.20	-3.50 – 7.60
Zinc 90 mg	0.00	-4.00 – 4.40

Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV- Secondary · between baseline and 24 Weeks

Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)

Systolic Blood Pressure (mmHg)

Group	Value	95% CI
Placebo	6.00	-4.00 – 12.00
Zinc 90 mg	0.00	-9.00 – 9.00

Diastolic Blood Pressure (mmHg)

Group	Value	95% CI
Placebo	3.00	-5.00 – 6.00
Zinc 90 mg	0.00	-5.00 – 5.00

Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects Secondary · between baseline and 24 Weeks

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

Group	Value	95% CI
Placebo	0.40	-1.10 – 2.00
Zinc 90 mg	0.00	-1.35 – 1.55

Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects Secondary · between baseline and 24 Weeks

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 1.6

Reactive Hyperemic Index

Group	Value	95% CI
Placebo	-0.34	-0.77 – 0.16
Zinc 90 mg	-0.18	-0.60 – 0.23

Augmentation Index

Group	Value	95% CI
Placebo	0.00	-8.00 – 5.50
Zinc 90 mg	-1.00	-7.00 – 6.00

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Zinc Gluconate

Serious: 1/63 (2%)

Deaths: 1/63

Placebo

Serious: 0/32 (0%)

Deaths: 0/32

Serious adverse events (1 terms)

Reaction	System	Zinc Gluconate	Placebo
Death	Injury, poisoning and procedural complications	—	—

Other adverse events (28 terms — click to expand)

Reaction	System	Zinc Gluconate	Placebo
High Glucose	Metabolism and nutrition disorders	—	—
High Triglycerides	Metabolism and nutrition disorders	—	—
High Creatinine	Renal and urinary disorders	—	—
High Cholesterol	Metabolism and nutrition disorders	—	—
High Uric Acid	Metabolism and nutrition disorders	—	—
High LDL	Metabolism and nutrition disorders	—	—
nausea	Gastrointestinal disorders	—	—
High ALT and/or AST	Hepatobiliary disorders	—	—
High Creatine Kinase	Musculoskeletal and connective tissue disorders	—	—
High Bilirubin	Hepatobiliary disorders	—	—
Stomach Pain	Gastrointestinal disorders	—	—
Low Hemoglobin	Blood and lymphatic system disorders	—	—
Low Phosphorus	General disorders	—	—
Low Sodium	General disorders	—	—
High Alkaline Phosphatase	Hepatobiliary disorders	—	—
Abdominal adhesions with intestinal torsion	Gastrointestinal disorders	—	—
Abcess post root canal	Gastrointestinal disorders	—	—
Bloating	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
High Blood Pressure	Cardiac disorders	—	—
Chest Pain	Cardiac disorders	—	—
Left groin hernia	Gastrointestinal disorders	—	—
Pain in right hip and Sciatica	Musculoskeletal and connective tissue disorders	—	—
Peripheral Neuropathy	Nervous system disorders	—	—
Scrotal Abcess	Skin and subcutaneous tissue disorders	—	—
Worsening of depression	Psychiatric disorders	—	—
High Sodium	General disorders	—	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT05085834 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Zinc Supplementation, Inflammation, and Gut Integrity Markers in HIV Infection: A Randomized Placebo-Controlled Trial.
   Baissary J, Koberssy Z, Wu Q, Sattar A, et al · · 2025 · cited 2× · PMID 40431411 · DOI 10.3390/nu17101671