Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 2,700
- Locations
- 3
- Primary Endpoint
- COVID-19 illness requiring hospitalization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
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
Intervention: PreserVision AREDS formulation soft gels or tablets (Dietary Supplement)
Multivitamin with 11mg of zinc
Subjects in this arm will have a multivitamin supplement with 11mg of zinc
Intervention: Multivitamin with 11mg of zinc (Dietary Supplement)
Outcomes
Primary Outcomes
COVID-19 illness requiring hospitalization
Time Frame: Through study completion, approximately 3 months
Total number of subjects admitted to the hospital in relations to COVID-19 illness PCR or undergo seroconversion
Secondary Outcomes
- Illness without hospitalization(Through study completion, approximately 3 months)
- Mortality(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)
Investigators
Atta Behfar
Principal Investigator
Mayo Clinic