Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Phase 3

Completed

• Conditions: Cervical Dysplasia
• Interventions: Drug: di indolylmethane (DIM); Dietary Supplement: Red rice bran

• Registration Number: NCT00212381
• Lead Sponsor: New York Presbyterian Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2000-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-01
• Study Completion: 2010-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral DIM (Active agent)	di indolylmethane (DIM)	2mg/kg/day po of DIM
Red rice bran (Placebo)	Red rice bran	this agent is not generally thought to be active but may be

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States