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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, Health Care Worker Patient Transmission, Aging

Intervention / Treatment
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* Dietary Supplement: PreserVision AREDS formulation soft gels or tablets
* Dietary Supplement: Multivitamin with 11mg of zinc


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose Zinc (PreserVision AREDS formulation soft gels or tablets)<br>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<br>* Two tabs taken daily for three months<br>|
| Active Comparator: Multivitamin with 11mg of zinc<br>Subjects in this arm will have a multivitamin supplement with 11mg of zinc | Dietary Supplement: Multivitamin with 11mg of zinc<br>* One tab taken daily for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illness without hospitalization | Total number of subjects with COVID-19 illness that are not hospitalized | Through study completion, approximately 3 months | 
| Supplemental oxygen therapy during hospitalization | Total number of subjects to require supplemental oxygen therapy during hospitalization for COVID-19 | Through study completion, approximately 3 months | 
| Invasive ventilation during hospitalization | Total number of subjects to require invasive ventilation during hospitalization for COVID-19 | Through study completion, approximately 3 months | 
| Mortality | Total number of subject deaths | Through study completion, approximately 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, Immune health