Zinc and Green Tea Extract for Community Respiratory Viral Infections

Last updated: May 15, 2024
Sponsor: University of Missouri-Columbia
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

Placebo

zinc-green tea extract-ascorbic acid

Clinical Study ID

NCT04898023
2035652
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form

  2. Stated willingness to comply with all study procedures and availability for theduration 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 dosingregimen

  5. Self-reported cold or flu symptoms for < 72 hours

Exclusion

Exclusion Criteria:

  1. Pregnant or actively seeking to become pregnant

  2. Positive for influenza with planned treatment with oseltamivir or baloxavir

  3. Current or planned treatment with an FDA regulated drug (including those under EUA)for COVID-19

  4. Chronic liver disease (i.e. baseline liver function tests (LFTs) > 1.5x the upperlimit of normal (ULN) or established cirrhosis

  5. Chronic renal failure stage 4 or greater

  6. History of kidney stones

  7. Acute secondary bacterial infection at the time of enrollment

  8. Requiring hospitalization for any reason at the time of enrollment

  9. History of copper or iron deficiency

  10. Current prescription for quinolone antibiotics, tetracycline antibiotics, orpenicillamine at the time of enrollment

  11. Allergy/intolerance to any of the active ingredients under investigation includingzinc citrate, green tea, and ascorbic acid (vitamin C)

  12. Patients without decision making capacity

  13. Currently enrolled in another clinical trial for a respiratory viral infection

Study Design

Total Participants: 17
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 21, 2022
Estimated Completion Date:
December 20, 2023

Connect with a study center

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

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