Back to resultsA RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
Primary Purpose
Genital Warts, HPV
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Oral Zinc
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Genital Warts focused on measuring Warts, HPV, Zinc
Eligibility Criteria
Inclusion Criteria:
- Adults age 19 and over
- Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
- Fluency in English
- Available within four days of the intended 8 week follow-up visit
Exclusion Criteria:
- Individuals under the age of 19
- Pregnant women
- Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
- Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
- Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
- Clients who have received standard of care treatment for their warts in the past month
Sites / Locations
- BC Centre for Disease Control
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oral Zinc
Placebo
Arm Description
Outcomes
Primary Outcome Measures
complete clearance of genital warts
Secondary Outcome Measures
Full Information
NCT ID
NCT01468636
First Posted
November 7, 2011
Last Updated
October 31, 2016
Sponsor
University of British Columbia
Collaborators
British Columbia Centre for Disease Control
1. Study Identification
Unique Protocol Identification Number
NCT01468636
Brief Title
A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
Official Title
A Randomized Controlled Trial to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
There was no clear benefit but numerous side effects.
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
British Columbia Centre for Disease Control
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Warts, HPV
Keywords
Warts, HPV, Zinc
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Zinc
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral Zinc
Intervention Description
200 mg BID of oral zinc gluconate x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
200mg BID x 8 weeks
Primary Outcome Measure Information:
Title
complete clearance of genital warts
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults age 19 and over
Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
Fluency in English
Available within four days of the intended 8 week follow-up visit
Exclusion Criteria:
Individuals under the age of 19
Pregnant women
Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
Clients who have received standard of care treatment for their warts in the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Lester
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Centre for Disease Control
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4R4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
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