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

NCT01468636 | Terminated Phase 4

• 1 other identifier: H11-01758
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Warts; HPV

Keywords

Warts; HPV; Zinc

Outcome Measures

Primary Outcomes (1)

• complete clearance of genital warts

  8 weeks

Study Arms (2)

Oral Zinc

ACTIVE COMPARATOR

Drug: Oral Zinc

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oral Zinc DRUG

200 mg BID of oral zinc gluconate x 8 weeks

Oral Zinc

Placebo DRUG

200mg BID x 8 weeks

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Centre for Disease Control: collaborator

Study Sites (1)

BC Centre for Disease Control

Vancouver, British Columbia, V5Z 4R4, Canada

Location

MeSH Terms

Conditions

Condylomata Acuminata; Warts

Interventions

Zinc

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Richard Lester

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

CA (1)