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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
This is the agent being studies. Similar agents have been reported to have potential activity.
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
NYU School of Medicine
New York, New York, United States
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
To determine if oral DIM is effective in promoting the regression of CIN in women
Time frame: 3 months
HPV colonization by commercial ELIZA test
To correlate the response to DIM with HPV colonization
Time frame: 3 months
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
To assess for any adverse effects of oral DIM in women
Time frame: one year
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