Zinc and Green Tea Extract for Community Respiratory Viral Infections

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)

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Viral Infection
• Intervention / Treatment: Drug: zinc-green tea extract-ascorbic acid; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ryan Camden, PharmD; Phone Number: 573 771 7179; Email: camdenr@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 < 72 hours

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 upper limit 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, or penicillamine at the time of enrollment
11. Allergy/intolerance to any of the active ingredients under investigation including zinc 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zinc-green tea extract-ascorbic acid; Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment.	Drug: zinc-green tea extract-ascorbic acid; Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
Placebo Comparator: Placebo; Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment.	Drug: Placebo; Compounded capsules containing microcrystalline cellulose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recovery from cold and flu-like symptoms	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)	7 days of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of patient-reported adverse events	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	7 days of follow-up
Rates of patient-reported days of absence and/or healthcare visits	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	7 days of follow-up

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 2035652

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No