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

NCT ID: NCT04551339

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-05-28

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.

Detailed Description

This is a two-cohort prospective randomized study intended to test the role of Zinc versus multivitamin supplementation in supporting immune health in the setting of the COVID-19 pandemic. Individuals over 50 years old or primary health care professionals over the age of 18 who have had no evidence of prior COVID-19 infection and who have been asymptomatic for 7 days prior to enrollment will be randomized at the individual level to take either PreserVision AREDS formulation soft gels or tablets with 69.6mg/day Zinc supplementation or to receive a multivitamin supplement with 11mg of zinc/day.

Conditions

Healthy; Health Care Worker Patient Transmission; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

PreserVision AREDS formulation soft gels or tablets

Intervention Type: DIETARY_SUPPLEMENT

Two tabs taken daily for three months

Multivitamin with 11mg of zinc

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

Group Type: ACTIVE_COMPARATOR

Multivitamin with 11mg of zinc

Intervention Type: DIETARY_SUPPLEMENT

One tab taken daily for three months

Interventions

PreserVision AREDS formulation soft gels or tablets

Two tabs taken daily for three months

Intervention Type: DIETARY_SUPPLEMENT

Multivitamin with 11mg of zinc

One tab taken daily for three months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

1. A history of solid organ or bone marrow transplantation

2. Subjects currently receiving chemotherapy

3. 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

4. Subjects with HIV or primary immunodeficiency syndromes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Atta Behfar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atta Behfar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Albert Hakaim, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Ayan Sen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Scottsdale

Scottsdale, Arizona, United States

Mayo Clinic in Jacksonville

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

20-004637

Identifier Type: -

Identifier Source: org_study_id