Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

March 27, 2017 updated by: Giuseppe Del Priore, New York Presbyterian Hospital

Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: oral DIM (Active agent)
2mg/kg/day po of DIM
Drug: di indolylmethane (DIM)
This is the agent being studies. Similar agents have been reported to have potential activity.
Active Comparator: Red rice bran (Placebo)
this agent is not generally thought to be active but may be
Dietary supplement: Red rice bran
this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
Time Frame: 3 months
To determine if oral DIM is effective in promoting the regression of CIN in women
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV colonization by commercial ELIZA test
Time Frame: 3 months
To correlate the response to DIM with HPV colonization
3 months
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
Time Frame: one year
To assess for any adverse effects of oral DIM in women
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Presbyterian 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9218

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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