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

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. Identifier: NCT01468636
Recruitment Status : Terminated (There was no clear benefit but numerous side effects.)
First Posted : November 9, 2011
Last Update Posted : November 2, 2016
British Columbia Centre for Disease Control
Information provided by (Responsible Party):
University of British Columbia

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01468636

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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
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Principal Investigator: Richard Lester University of British Columbia

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Responsible Party: University of British Columbia Identifier: NCT01468636     History of Changes
Other Study ID Numbers: H11-01758
H11-01758 ( Other Identifier: UBC IRB number )
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Keywords provided by University of British Columbia:
Additional relevant MeSH terms:
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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
Trace Elements
Growth Substances
Physiological Effects of Drugs