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

HPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01468636
• Other study ID #: H11-01758
• Secondary ID: H11-01758
• Status: Terminated
• Phase: Phase 4
• First received: November 7, 2011
• Last updated: October 31, 2016
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada:None required
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• HPV
• Warts

Intervention

Drug:
• Oral Zinc
200 mg BID of oral zinc gluconate x 8 weeks
• Placebo
200mg BID x 8 weeks

Locations

Country	Name	City	State
Canada	BC Centre for Disease Control	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	British Columbia Centre for Disease Control

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete clearance of genital warts		8 weeks	No