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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Genital Warts, HPV

Intervention / Treatment
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* Drug: Oral Zinc
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Zinc<br> | Drug: Oral Zinc<br>* 200 mg BID of oral zinc gluconate x 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 200mg BID x 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete clearance of genital warts |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Warts, HPV, Zinc