A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts

October 31, 2016 updated by: University of British Columbia

A Randomized Controlled Trial to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts

The purpose of this study is to examine the effect of 400 mg of oral zinc gluconate on genital warts. Our hypothesis is that there will be a 10% difference in complete clearance of genital warts in the group randomized to oral plus standard of care compared to those randomized to placebo plus standard of care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Clients presenting to the BCCDC STI clinic with genital warts will be randomized to either 400 mg zinc gluconate or placebo (200mg BID) for 8 weeks in addition to the standard of care. Clinical assessment of warts and additional standard treatment will occur every 7-10 days for a maximum of 8 weeks. A telephone call will occur at week 20 to determine if any of the warts have cleared or re-appeared. The appearance of new warts will also be noted. The proportion of subjects who have complete clearance of genital warts at 8 weeks will be compared between groups.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4R4
        • BC Centre for Disease Control

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

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults age 19 and over
  2. Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
  3. Fluency in English
  4. Available within four days of the intended 8 week follow-up visit

Exclusion Criteria:

  1. Individuals under the age of 19
  2. Pregnant women
  3. Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
  4. Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
  5. Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
  6. Clients who have received standard of care treatment for their warts in the past month

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
200mg BID x 8 weeks
Active Comparator: Oral Zinc
Drug: Oral Zinc
200 mg BID of oral zinc gluconate x 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete clearance of genital warts
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

British Columbia Centre for Disease Control

Investigators

  • Principal Investigator: Richard Lester, University of British Columbia

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

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-01758 (Other Identifier: UBC IRB number)

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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