An investigation into the effects of diindolylmethane (BioResponse DIM®) supplementation in women with low-grade cervical cytological abnormalities
| ISRCTN | ISRCTN47437431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47437431 |
| ClinicalTrials.gov number | NCT00462813 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/09/2005
- Registration date
- 25/10/2005
- Last edited
- 19/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Peter Sasieni
Scientific
Scientific
Wolfson Institute
Queen Mary College
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)207 014 0260 |
|---|---|
| peter.sasieni@cancer.org.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation into the effects of diindolylmethane (BioResponse DIM®) supplementation in women with low-grade cervical cytological abnormalities |
| Study acronym | CRISP-1 |
| Study objectives | DIM® will prevent progression and accelerate regression of cervical intra-epithelial neoplasia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cervical neoplasia. |
| Intervention | Double-blind, placebo-controlled trial. Randomisation is in the ratio 2 DIM®: 1 placebo. Diindolylmethane (BioResponse DIM® - 75 mg capsules) - two capsules daily for 6 months. |
| Intervention type | Other |
| Primary outcome measure | Reduction in cervical intra-epithelial neoplasia grade 2 (CIN2) or worse. |
| Secondary outcome measures | Cytology, lesion size, human papillomavirus (HPV) status (all at 6 months). |
| Overall study start date | 25/10/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3000 |
| Key inclusion criteria | Women with a first mildly dyskaryotic smear or a second borderline smear taken within the Cervical Screening Wales (CSW) programme will be invited to participate in the trial. |
| Key exclusion criteria | N/A |
| Date of first enrolment | 25/10/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wolfson Institute
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Sponsor information
Queen Mary and Westfield College, University of London (UK)
University/education
University/education
Joint R and D Office
3rd Floor Rutland House
42-46 New Road
London
E1 2AX
England
United Kingdom
| Phone | +44 (0)207 882 7272 |
|---|---|
| Helen.Cadiou@bartsandthelondon.nhs.uk | |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Cancer Research UK (C8162/A4609).
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 03/01/2012 | Yes | No |
Editorial Notes
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
