Clinical trial NCT05085834: Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Official title: Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Inflammation
Cardiovascular Diseases
Zinc Deficiency
Keywords: Zinc
inflammation
Cardiovascular Diseases risk
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-10-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 weeks
measure: Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc on oxLDL in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
Secondary outcomes:
measure: Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
measure: Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects
timeFrame: between baseline and 24 Weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace A McComsey, MD, FIDSA
role: PRINCIPAL_INVESTIGATOR
References: