Zinc Sulfate for Human Papillomavirus (HPV)

September 21, 2023 updated by: Spectrum Health Hospitals

Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high risk HPV versus placebo.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Upon enrollment eligible participants will be randomized and given a three-month supply of zinc sulfate or placebo to be taken as directed. They will have zinc serum lab testing at enrollment and upon study completion. Patients will also be asked to complete short questionnaires and to make study staff aware of any side effects they should experience.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Abnormal cytology of atypical squamous cells of undetermined significance (ASCUS) on Pap smear OR
  • Low-grade squamous intra epithelial lesions (LSIL) on Pap smear OR
  • Positive hrHPV on routine screening (positive HPV will be assumed to be high grade)

Exclusion Criteria:

  • Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
  • Pregnant patients
  • Breastfeeding patients
  • Immunocompromised patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Zinc Sulfate 220mg twice daily for three months.
Dietary supplement: Zinc Sulfate
Participant will take one 220mg tablet twice daily for three months.
Placebo Comparator: Placebo
Gelatin Placebo tablet twice daily for three months.
Other: Placebo (Gelatin Tablet)
Participant will take one tablet twice daily for three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clearance rates of high risk HPV
Time Frame: During 3 month treatment period
During 3 month treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression versus Regression
Time Frame: During 3 month treatment period
Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate
During 3 month treatment period
Side Effects
Time Frame: After 3 month treatment period
Rates of side effects from zinc sulfate
After 3 month treatment period
Compliance Rates
Time Frame: After 3 month treatment period
Examine rates of patients finishing the 3-month course of zinc sulfate
After 3 month treatment period
Parity
Time Frame: After 3 month treatment period
Examine the correlation of parity on HPV clearance
After 3 month treatment period
Low Zinc Levels and Persistence
Time Frame: After 3 month treatment period
Examine potential correlation between low serum levels of zinc and persistence of HPV.
After 3 month treatment period
Zinc Levels and Regression
Time Frame: After 3 month treatment period
Examine the relation between zinc levels before and after treatment and the relation to regression of HPV.
After 3 month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Investigators

  • Principal Investigator: Rebecca Prudnick, DO, Spectrum Health Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

November 27, 2017

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-Zinc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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