A COVID Study to Compare Impact of Zinc Supplementation versus Multivitamin to Support Immune Health

Overview

Información sobre este estudio

The purpose of this study is compare high dose (69.6 mg/day) Zinc to multivitamin supplementation on immune health as used by primary health care staff and individuals over 50 years old identified, by hypothesis generated from observations among the pandemic to date, as being at risk populations to COVID-19. In order to ensure consistent nutritional supplementation, the PreserVision AREDS formulation gel tabs will be recommended for those randomized to Zinc and the Adult (under 50) Centrum formulation recommended for those randomized to multivitamin.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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 100.0 degrees 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 (Close contact is defined by CDC as:  being within approximately 6 feet of a COVID-19 patient for a prolonged period of time (more than 5 minutes) 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 positive or indeterminate Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening.
  • Active symptoms of COVID ((a fever of 100.0 degrees 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 Centrum multivitamins or Zinc supplement 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Atta Behfar, M.D., Ph.D.

Cerrado para la inscripción

Contact information:

Atta Behfar M.D., Ph.D.

(507) 422-6736

ZnCOVIDStudy@mayo.edu

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Albert Hakaim, M.D.

Cerrado para la inscripción

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Ayan Sen, M.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publicaciones

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CLS-20491535

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