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

This study is not yet open for participant recruitment.
Verified November 2011 by University of British Columbia
Sponsor:
Collaborator:
British Columbia Centre for Disease Control
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01468636
First received: November 7, 2011
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Genital Warts
HPV
 Drug: Oral Zinc
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: Genital Warts Warts
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • complete clearance of genital warts [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 242
Study Start Date: November 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468636

Contacts
Contact: Richard Lester, MD 604-707-5606 richard.lester@bccdc.ca
Contact: Darlene Taylor, PhD(c) 604-707-5612 darlene.taylor@bccdc.ca

Locations
Canada, British Columbia
BC Centre for Disease Control Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4R4
Contact: Darlene Taylor, PhD(c)     604-707-5612     darlene.taylor@bccdc.ca    
Contact: Richard Lester, MD     604-707-5606     richard.lester@bccdc.ca    
Principal Investigator: Richard Lester, MD            
Sponsors and Collaborators
University of British Columbia
British Columbia Centre for Disease Control
Investigators
Principal Investigator: Richard Lester University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01468636     History of Changes
Other Study ID Numbers: Oral Zinc RTC, H11-01758
Study First Received: November 7, 2011
Last Updated: November 15, 2011
Health Authority: Canada:None required

Keywords provided by University of British Columbia:
Warts
HPV
Zinc

Additional relevant MeSH terms:
Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
 Skin Diseases, Infectious
Skin Diseases
Neoplasms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013