Clinical trial NCT03404310: Zinc Sulfate for Human Papillomavirus (HPV)
Official title: Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: HPV
ASCUS
LSIL
Cervical Cancer
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 21
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clearance rates of high risk HPV
timeFrame: During 3 month treatment period
Secondary outcomes:
measure: Progression versus Regression
timeFrame: During 3 month treatment period
measure: Side Effects
timeFrame: After 3 month treatment period
measure: Compliance Rates
timeFrame: After 3 month treatment period
measure: Parity
timeFrame: After 3 month treatment period
measure: Low Zinc Levels and Persistence
timeFrame: After 3 month treatment period
measure: Zinc Levels and Regression
timeFrame: After 3 month treatment period
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Rebecca Prudnick, DO
role: PRINCIPAL_INVESTIGATOR
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