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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 has been terminated.
(There was no clear benefit but numerous side effects.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01468636
First Posted: November 9, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Columbia Centre for Disease Control
Information provided by (Responsible Party):
University of British Columbia
  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
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • complete clearance of genital warts [ Time Frame: 8 weeks ]

Enrollment: 50
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468636


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

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 Submitted: November 7, 2011
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