Zinc Supplementation and Cardiovascular Risk in HIV

NCT02856269 | Completed Results DMC

• 2 other identifiers: 02-15-071R21AT009153-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.

Conditions

HIV; Inflammation

Keywords

Zinc

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)

  Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.

  Baseline and 16 Weeks

Secondary Outcomes (1)

• Percentage of Participants That Reached the Zinc Sufficient Level After Treatment

  16 Weeks

Study Arms (2)

45 mg daily

ACTIVE COMPARATOR

Participants in this arm will take a daily 45 mg dose of zinc gluconate.

Dietary Supplement: Zinc gluconate

90 mg daily

ACTIVE COMPARATOR

Participants in this arm will take a daily 90 mg dose of zinc gluconate.

Dietary Supplement: Zinc gluconate

Interventions

Zinc gluconate DIETARY_SUPPLEMENT

Participants will take a daily dose of zinc gluconate.

45 mg daily; 90 mg daily

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
• Age ≥18 years
• Zinc level ≤0.75 mg/L
• Receiving a stable antiretroviral regimen with no plans to change during study
• Documentation of an HIV-1 RNA level of ≤400 copies/mL
• No diarrhea or nausea/vomiting for the last month

You may not qualify if:

• Pregnancy/lactation
• Presence of inflammatory condition
• Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
• Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
• Known cardiovascular disease
• Uncontrolled diabetes
• Allergy or intolerance to zinc sulfate.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 x Upper limit of normal (ULN)
• Hemoglobin \< 9.0 g/dL
• glomerular filtration rate (GFR) \< 50 mL/min

Sponsors & Collaborators

• Grace McComsey: lead
• 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

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the small sample size and short study period, we cannot establish causation. We did not include a placebo control group for comparison. Our study focused on participants with treated HIV and documented zinc deficiency in the United States. We did not obtain dietary or physical activity patterns. Participants with treated HIV and documented zinc deficiency resided in the United States, therefore our findings cannot be generalized to different populations or to resource limited settings.

Results Point of Contact

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

Grace.McComsey@UHhospitals.org

216-8442739

Study Officials

• Grace McComsey, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 4, 2016
• Study Start: September 1, 2016
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: February 11, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)