Zinc Sulfate for Human Papillomavirus (HPV)

Not Applicable

Terminated

• Conditions: Human Papilloma Virus
• Interventions: Dietary Supplement: Zinc Sulfate; Other: Placebo (Gelatin Tablet)

• Registration Number: NCT03404310
• Lead Sponsor: Spectrum Health Hospitals

Brief Summary

The Human Papillomavirus (HPV) is well established as the primary causative agent in both warts and cervical cancer. Although cervical high risk HPV (hrHPV) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. Zinc has been shown to play a central role in immunity. This study is to determine if oral zinc sulfate can improve clearance rates of high risk HPV versus placebo.

Detailed Description

Upon enrollment eligible participants will be randomized and given a three-month supply of zinc sulfate or placebo to be taken as directed. They will have zinc serum lab testing at enrollment and upon study completion. Patients will also be asked to complete short questionnaires and to make study staff aware of any side effects they should experience.

Study Timeline

• Study Start: 2017-10-24
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-19
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Abnormal cytology of atypical squamous cells of undetermined significance (ASCUS) on Pap smear OR
• Low-grade squamous intra epithelial lesions (LSIL) on Pap smear OR
• Positive hrHPV on routine screening (positive HPV will be assumed to be high grade)

Exclusion Criteria

• Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
• Pregnant patients
• Breastfeeding patients
• Immunocompromised patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Zinc Sulfate	Zinc Sulfate 220mg twice daily for three months.
Placebo	Placebo (Gelatin Tablet)	Gelatin Placebo tablet twice daily for three months.

Primary Outcome Measures

Name	Time	Method
Clearance rates of high risk HPV	During 3 month treatment period

Secondary Outcome Measures

Name	Time	Method
Low Zinc Levels and Persistence	After 3 month treatment period	Examine potential correlation between low serum levels of zinc and persistence of HPV.
Side Effects	After 3 month treatment period	Rates of side effects from zinc sulfate
Compliance Rates	After 3 month treatment period	Examine rates of patients finishing the 3-month course of zinc sulfate
Parity	After 3 month treatment period	Examine the correlation of parity on HPV clearance
Progression versus Regression	During 3 month treatment period	Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate
Zinc Levels and Regression	After 3 month treatment period	Examine the relation between zinc levels before and after treatment and the relation to regression of HPV.

Trial Locations

Locations (1)

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States