Zinc and Green Tea Extract for Community Respiratory Viral Infections

Respiratory Viral Infection Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04898023
• Other study ID #: 2035652
• Status: Terminated
• Phase: Phase 2
• Start date: September 21, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 20, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Viral Infection
• Virus Diseases

Intervention

Drug:
• zinc-green tea extract-ascorbic acid
Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
• Placebo
Compounded capsules containing microcrystalline cellulose.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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