Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19

NCT04551339 | Completed

• 1 other identifier: 20-004637
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to look at high dose zinc versus multivitamin micronutrient supplementation to support immune health in the setting of the COVID-19 pandemic.

Conditions

Healthy; Health Care Worker Patient Transmission; Aging

Keywords

Zinc; Immune health

Outcome Measures

Primary Outcomes (1)

• COVID-19 illness requiring hospitalization

  Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion

  Through study completion, approximately 3 months

Secondary Outcomes (4)

• Illness without hospitalization

  Through study completion, approximately 3 months

• Supplemental oxygen therapy during hospitalization

  Through study completion, approximately 3 months

• Invasive ventilation during hospitalization

  Through study completion, approximately 3 months

• Mortality

  Through study completion, approximately 3 months

Study Arms (2)

High dose Zinc (PreserVision AREDS formulation soft gels or tablets)

ACTIVE COMPARATOR

Subjects will have a high dose Zinc supplementation in combination with Copper, Vitamin C/E and beta-carotene

Dietary Supplement: PreserVision AREDS formulation soft gels or tablets

Multivitamin with 11mg of zinc

ACTIVE COMPARATOR

Subjects in this arm will have a multivitamin supplement with 11mg of zinc

Dietary Supplement: Multivitamin with 11mg of zinc

Interventions

PreserVision AREDS formulation soft gels or tablets DIETARY_SUPPLEMENT

Two tabs taken daily for three months

High dose Zinc (PreserVision AREDS formulation soft gels or tablets)

Multivitamin with 11mg of zinc DIETARY_SUPPLEMENT

One tab taken daily for three months

Multivitamin with 11mg of zinc

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years old OR primary healthcare professional (defined as having a job that has had direct patient contact during the COVID-19 pandemic) and ≥18 years old
• No symptoms of COVID-19 (a fever of 100.0o F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation) in the past 7 days
• Have a negative Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening
• Have not had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 without full PPE (Close contact is defined by CDC as: Being within approximately 6 feet of a COVID-19 patient for a total of 15 minutes or more over a 24 hour period) or having direct contact with infectious secretions of a COVID-19 patient (e.g. being coughed on)) in the last 14 days
• Mayo Clinic patient who has a patient online account set up or is willing to set up an online account
• Must have a valid email address and internet service

You may not qualify if:

• History of positive or indeterminate COVID PCR test prior to screening or Elecsys Anti-SARS-CoV-2 immunoassay antibody test positive or indeterminate at screening
• Active symptoms of COVID ((a fever of 100.0o F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation)) in past 7 days
• Known intolerance to multivitamins or zinc supplements from prior exposure
• Inability to complete follow-up questions or grant access to electronic health record for surveillance
• Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in past 14 days
• Current or former smoker less than 5 years ago
• Pregnant or breastfeeding
• Prisoner
• Any subject with known immunosuppressed state, including
• A history of solid organ or bone marrow transplantation
• Subjects currently receiving chemotherapy
• Current rheumatologic or autoimmune illness requiring treatment with glucocorticoids, antimetabolite agents (methotrexate, azathioprine, mercaptopurine, fluorouracil, mycophenolate, leflunomide), IMIDs (lenalidomide, thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine), mTOR inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs (including any drug given intravenously or subcutaneously) for the purpose of immunosuppression
• Subjects with HIV or primary immunodeficiency syndromes

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Tablets; Geritol; Zinc

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Atta Behfar, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Albert Hakaim, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Ayan Sen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 28, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

US (3)