Human Papilloma Virus
Conditions
Keywords
HPV, ASCUS, LSIL, Cervical Cancer
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.
Interventions
DIETARY_SUPPLEMENTZinc Sulfate
Participant will take one 220mg tablet twice daily for three months.
OTHERPlacebo (Gelatin Tablet)
Participant will take one tablet twice daily for three months.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single-blinded placebo controlled
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance rates of high risk HPV | During 3 month treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Progression versus Regression | During 3 month treatment period | Incidence of progression versus regression of cervical changes after treatment with oral zinc sulfate |
| Low Zinc Levels and Persistence | After 3 month treatment period | Examine potential correlation between low serum levels of zinc and persistence of HPV. |
| 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. |
| Parity | After 3 month treatment period | Examine the correlation of parity on HPV clearance |
Countries
United States
Outcome results
None listed