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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Genital Warts; HPV	Drug: Oral Zinc; Drug: Placebo	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
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 Start Date :	November 2011
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. complete clearance of genital warts [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of British Columbia

British Columbia Centre for Disease Control

Investigators

Principal Investigator:	Richard Lester	University of British Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT01468636 History of Changes
Other Study ID Numbers:	H11-01758; H11-01758 ( Other Identifier: UBC IRB number )
First Posted:	November 9, 2011
Last Update Posted:	November 2, 2016
Last Verified:	October 2016

Keywords provided by University of British Columbia:

Warts; HPV; Zinc

Additional relevant MeSH terms:

Warts; Condylomata Acuminata; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious	Skin Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Zinc; Trace Elements; Micronutrients; Growth Substances; Physiological Effects of Drugs