Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

New York Presbyterian Hospital

Status and phase: Completed; Phase 3

Conditions: Cervical Dysplasia

Treatments: Dietary Supplement: Red rice bran; Drug: di indolylmethane (DIM)

Study type: Interventional

Funder types: Other

Identifiers

NCT00212381

9218

Details and patient eligibility

About

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.

Full 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

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

oral DIM (Active agent)

Experimental group

Description:

2mg/kg/day po of DIM

Treatment:

Drug: di indolylmethane (DIM)

Red rice bran (Placebo)

Active Comparator group

Description:

this agent is not generally thought to be active but may be

Treatment:

Dietary Supplement: Red rice bran