Oral Zinc Sulfate for the Treatment of High Risk Cervical HPV Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Clearance rates of high risk HPV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blinded placebo controlled
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization)
- •Pregnant patients
- •Breastfeeding patients
- •Immunocompromised patients
结局指标
主要结局
Clearance rates of high risk HPV
时间窗: During 3 month treatment period
次要结局
- Low Zinc Levels and Persistence(After 3 month treatment period)
- Side Effects(After 3 month treatment period)
- Compliance Rates(After 3 month treatment period)
- Parity(After 3 month treatment period)
- Progression versus Regression(During 3 month treatment period)
- Zinc Levels and Regression(After 3 month treatment period)