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Zinc and Green Tea Extract for Community Respiratory Viral Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04898023
Recruitment Status : Not yet recruiting
First Posted : May 24, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
Zinc and green tea supplementation have both been independently studied for supporting immune health during cold and flu-like illness in non-hospitalized patients with clinical trials demonstrating promising but inconsistent results. Combination therapy may offer an improved effect as the antioxidant compounds found in green tea have been shown to increase cellular zinc concentrations thereby inhibiting viral replication. This study seeks to evaluate the effect of combination supplementation using established doses of zinc and green tea extract on symptom duration and severity from cold and flu-like illness, including COVID-19, in adult community patients enrolled in a randomized placebo-controlled trial.

Condition or disease Intervention/treatment Phase
Respiratory Viral Infection Drug: zinc-green tea extract-ascorbic acid Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Combination Zinc and Green Tea Extract Supplementation on Reduction in Symptom Duration and Severity Associated With Community Respiratory Viral Infections: a Randomized Control Trial (ZiPhenol Study)
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: zinc-green tea extract-ascorbic acid
Compounded capsules will be prepared containing each 50mg of zinc citrate, 400mg of green tea extract, and 100mg of ascorbic acid. Randomized patients will take two (2) capsules taken orally two (2) hours following a meal twice daily x5 days.
Drug: zinc-green tea extract-ascorbic acid
Compounded capsules

Placebo Comparator: Placebo

Compounded capsules will be prepared containing each 650mg of microcrystalline cellulose.

Randomized patients will take two (2) capsules taken orally two (2) hours following a meal twice daily x5 days

Drug: zinc-green tea extract-ascorbic acid
Compounded capsules




Primary Outcome Measures :
  1. Rate of recovery from cold and flu-like symptoms [ Time Frame: 7 days of follow-up ]
    Rate of recovery is defined as achieving a daily total symptom severity score of 0 or 1 within 7 days using an established 12 symptom scoring system with a severity scale ranging from 0-absent to 3-very severe for each symptom (max of 36 points)


Secondary Outcome Measures :
  1. Rates of patient-reported adverse events [ Time Frame: 7 days of follow-up ]
    Adverse events to be collected include: nausea, vomiting, indigestion, worsening of shortness of breath or difficulty breathing, allergic reaction including skin rash, and need to seek medical care (e.g. hospitalization or physician visit) for a suspected study drug related adverse effect

  2. Rates of patient-reported days of absence and/or healthcare visits [ Time Frame: 7 days of follow-up ]
    Absence will include missed days from work or school and healthcare visits will include hospitalization or physician office visit(s) for respiratory viral illness related complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 years and older
  4. Ability to take oral medication and be willing to adhere to the prescribed dosing regimen
  5. Self-reported cold or flu symptoms for ≤ 36 hours

Exclusion Criteria:

  1. Pregnant or actively seeking to become pregnant
  2. Positive for influenza with planned treatment with oseltamivir or baloxavir
  3. Chronic liver disease
  4. Acute secondary bacterial infection at the time of enrollment
  5. Requiring hospitalization for any reason at the time of enrollment
  6. History of copper or iron deficiency
  7. Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment
  8. Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C)
  9. Patients without decision making capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898023


Contacts
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Contact: Ryan Camden, PharmD 573 771 7179 camdenr@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04898023    
Other Study ID Numbers: 2035652
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients