Zinc Sulfate for Human Papillomavirus (HPV)

Study Overview
=================
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.

Official Title
-----------------
Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo

Conditions
-----------------
Human Papilloma Virus

Intervention / Treatment
-----------------
* Dietary Supplement: Zinc Sulfate
* Other: Placebo (Gelatin Tablet)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Zinc Sulfate 220mg twice daily for three months. | Dietary Supplement: Zinc Sulfate<br>* Participant will take one 220mg tablet twice daily for three months.<br>|
| Placebo Comparator: Placebo<br>Gelatin Placebo tablet twice daily for three months. | Other: Placebo (Gelatin Tablet)<br>* Participant will take one tablet twice daily for three months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance rates of high risk HPV |  | During 3 month treatment period | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, ASCUS, LSIL, Cervical Cancer