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

NCT ID: NCT01468636

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-01-31

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.

Conditions

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Genital Warts HPV

Keywords

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Warts HPV Zinc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Oral Zinc

Group Type ACTIVE_COMPARATOR

Oral Zinc

Intervention Type DRUG

200 mg BID of oral zinc gluconate x 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

200mg BID x 8 weeks

Interventions

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Oral Zinc

200 mg BID of oral zinc gluconate x 8 weeks

Intervention Type DRUG

Placebo

200mg BID x 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Columbia Centre for Disease Control

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lester

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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BC Centre for Disease Control

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H11-01758

Identifier Type: OTHER

Identifier Source: secondary_id

H11-01758

Identifier Type: -

Identifier Source: org_study_id