Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
研究概览
简要总结
To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.
详细描述
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
central pharmacy dispenses based on sealed randomization table
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non pregnant women greater than or equal to 18 years of age able to consent
- •CIN II or III confirmed by histology
- •Karnofsky performance status >= 80
- •No prior treatment for dysplasia in the past 4 months
排除标准
- •Incompletely visible lesion
- •Diethylstilbestrol (DES) exposure
- •HIV seropositive
研究组 & 干预措施
oral DIM (Active agent)
2mg/kg/day po of DIM
干预措施: di indolylmethane (DIM) (Drug)
Red rice bran (Placebo)
this agent is not generally thought to be active but may be
干预措施: Red rice bran (Dietary Supplement)
结局指标
主要结局
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
时间窗: 3 months
To determine if oral DIM is effective in promoting the regression of CIN in women
次要结局
- Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20(one year)
- HPV colonization by commercial ELIZA test(3 months)
研究者
Giuseppe Del Priore
Professor
New York Presbyterian Hospital