Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

This study is currently recruiting participants.

Verified by New York Downtown Hospital, September 2005

First Received: September 13, 2005 No Changes Posted

Sponsor:	New York Downtown Hospital
Information provided by:	New York Downtown Hospital
ClinicalTrials.gov Identifier:	NCT00212381

Purpose

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.

Condition	Intervention	Phase
Cervical Dysplasia	Drug: diindolylmethane (DIM)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by New York Downtown Hospital:

Primary Outcome Measures:

To determine if oral DIM is effective in promoting the regression of CIN in women

Secondary Outcome Measures:

To correlate the response to DIM with HPV colonization
To assess for any adverse effects of oral DIM in women

Estimated Enrollment:	62
Study Start Date:	September 2000
Estimated Study Completion Date:	August 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212381

Contacts

Contact: Roopa R Chakkappan, M.P.H

212-312-5268

roopa.chakkappan@downtownhospital.org

Locations

United States, New York
NYU School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Alan Arslan, M.D. 212-263-7792 akhmea01@popmail.med.nyu.edu
Contact: Giuseppe Del Priore, M.D, M.P.H. 212-312-5268 giuseppe.delpriore@downtownhospital.org

Sponsors and Collaborators

New York Downtown Hospital

Investigators

Study Director:	Giuseppe Del Priore, M.D., M.P.H.	NY Downtown Hospital
Principal Investigator:	Alan Arslan, M.D.	NYU School of Medicine

More Information

No publications provided

Study ID Numbers:	9218
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00212381 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York Downtown Hospital:

cervical dysplasia, diindolylmethane, pap smear

Additional relevant MeSH terms:

Genital Diseases, Female
Uterine Cervical Diseases
Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions
Carcinoma in Situ

Uterine Diseases
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on February 08, 2010