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

Not Applicable

Completed

• Conditions: Health Care Worker Patient Transmission; Healthy; Aging
• Interventions: Dietary Supplement: Multivitamin with 11mg of zinc; Dietary Supplement: PreserVision AREDS formulation soft gels or tablets

• Registration Number: NCT04551339
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-16
• Study Start: 2020-09-28
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-07
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2700

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multivitamin with 11mg of zinc	Multivitamin with 11mg of zinc	Subjects in this arm will have a multivitamin supplement with 11mg of zinc
High dose Zinc (PreserVision AREDS formulation soft gels or tablets)	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

Primary Outcome Measures

Name	Time	Method
COVID-19 illness requiring hospitalization	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 Outcome Measures

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

Trial Locations

Locations (3)

Mayo Clinic in Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Jacksonville; 🇺🇸 Jacksonville, Florida, United States