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

Healthy Clinical Trial

— ZnCOVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551339
• Other study ID #: 20-004637
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: August 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2700
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Health Care Worker Patient Transmission
• Healthy

Intervention

Dietary Supplement:
• PreserVision AREDS formulation soft gels or tablets
Two tabs taken daily for three months
• Multivitamin with 11mg of zinc
One tab taken daily for three months

Locations

Country	Name	City	State
United States	Mayo Clinic in Jacksonville	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Scottsdale	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Illness without hospitalization	Total number of subjects with COVID-19 illness that are not hospitalized	Through study completion, approximately 3 months
Secondary	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
Secondary	Invasive ventilation during hospitalization	Total number of subjects to require invasive ventilation during hospitalization for COVID-19	Through study completion, approximately 3 months
Secondary	Mortality	Total number of subject deaths	Through study completion, approximately 3 months

External Links

•   Mayo Clinic Clinical Trials