Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
18 Years
80 Years
Female
Cervical Dysplasia
Trial Information
Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
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
Inclusion Criteria:
- 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
Exclusion Criteria:
- Incompletely visible lesion
- Diethylstilbestrol (DES) exposure
- HIV seropositive
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
To determine if oral DIM is effective in promoting the regression of CIN in women
Principal Investigator
Giuseppe Del Priore, M.D., M.P.H.
Investigator Role:
Study Director
Investigator Affiliation:
NY Downtown Hospital
Authority:
United States: Food and Drug Administration
Study ID:
9218
NCT ID:
NCT00212381
Start Date:
September 2000
Completion Date:
August 2005
Related Keywords:
- Cervical Dysplasia
- cervical dysplasia, diindolylmethane, pap smear
- Uterine Cervical Dysplasia
- Cervical Intraepithelial Neoplasia
Name | Location |
|---|---|
| NYU School of Medicine | New York, New York 10016 |
