A RTC to Examine the Effectiveness of 400 mg of Oral Zinc Gluconate as Adjunctive Therapy for Ano-genital Warts
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of British Columbia
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
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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:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adults age 19 and over
- Clinical diagnosis of genital warts requiring treatment based on clinician evaluation
- Fluency in English
- Available within four days of the intended 8 week follow-up visit
Exclusion Criteria:
- Individuals under the age of 19
- Pregnant women
- Known contraindication to zinc Signs of copper/iron deficiency which include anemia and neutropenia which are characterized by tiredness, fatigue and light headedness.
- Diseases that alter zinc metabolism or absorption eg. type II diabetes mellitus, Crohn's disease, chronic leg ulcers
- Clients who are currently taking zinc for therapeutic purposes or have taken zinc in the last two months for therapeutic purposes
- Clients who have received standard of care treatment for their warts in the past month
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468636
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
| 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:
|
Condylomata Acuminata Warts 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 |
ClinicalTrials.gov processed this record on September 28, 2016