Clinical Trial: Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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
Sponsor: New York Presbyterian Hospital

Current Primary Outcome: 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


Original Primary Outcome: To determine if oral DIM is effective in promoting the regression of CIN in women

Current Secondary Outcome:

  • HPV colonization by commercial ELIZA test [ Time Frame: 3 months ]
    To correlate the response to DIM with HPV colonization
  • 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


Original Secondary Outcome:

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


Information By: New York Presbyterian Hospital

Dates:
Date Received: September 13, 2005
Date Started: September 2000
Date Completion:
Last Updated: March 27, 2017
Last Verified: March 2017