Official Title
Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
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.

Completed
Healthy
Health Care Worker Patient Transmission
Aging

Dietary Supplement: PreserVision AREDS formulation soft gels or tablets

Two tabs taken daily for three months

Dietary Supplement: Multivitamin with 11mg of zinc

One tab taken daily for three months

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 90 Years
Countries
United States
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

NCT Number
Keywords
Zinc
Immune health