| Source of record | UK Trials |
| ISRCTN | ISRCTN43577261 |
| Date ISRCTN assigned | 06/10/2006 |
| Local reference number(s) | JQADGAR |
| Public title | The influence of methylenetetrahydrofolate reductase C677T genotype and folate status on deoxyribonucleic acid methylation and uracil misincorporation in the colon of healthy volunteers |
| Scientific title |
|
| Acronym | FolGene |
| Disease/condition/study domain | Colorectal cancer |
| Study hypothesis | Increasing folate status and the MethyleneTetraHydroFolate Reductase (MTHFR) C677T genotype influence intermediary biomarkers of preclinical neoplasia (DeoxyriboNucleic Acid [DNA] methylation and uracil misincorporation) in human colonic epithelium. |
| Design/methodology | Randomised, double blind, placebo controlled, parallel study |
| Research ethics review | King's College Hospital Research Ethics Committee approval received 13 July 2006 (reference Number 06/Q0703/29). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | No lesions detected on full colonoscopy |
| Participants - exclusion criteria | 1. Colorectal polyps or cancer discovered at present colonoscopy
2. Current or previous diagnosis of cancer, or a strong family history of colorectal cancer or adenomatous polyposis coli
3. Inflammatory bowel disease
4. Current or past history of gluten-sensitive enteropathy
5. Clinical and/or laboratory evidence of intestinal malabsorption
6. Significant renal or liver disease
7. Pregnancy
8. Epilepsy
9. Alcoholism
10. Pernicious anaemia
11. Serum vitamin B12 levels less than 180 ng/l and the use of medication known to antagonise the metabolism of folate |
| Patient information material |
|
| Anticipated start date | 11/09/2006 |
| Anticipated end date | 11/09/2009 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | 400 µg per day folic acid or placebo for three months. |
| Primary outcome measure(s) | Changes in genomic and gene specific DNA methylation and uracil misincorporation. |
| Secondary outcome measure(s) | Changes in blood and tissue folate and plasma homocysteine. |
| Sources of funding | Biotechnology and Biological Sciences Research Council (BBSRC) (reference number: BB/D523178/1) |
| Sponsor name | Nutritional Sciences Research Division (UK) |
| Sponsor details | King's College London
Hodkin Building
Guy's Campus
London
United Kingdom
SE1 1UL |
| Sponsor website | http://www.kcl.ac.uk |
| Contact name | Dr Maria Pufulete |
| Contact details | King's College London
Franklin-Wilkins Building
150 Stamford Street
Waterloo
London
United Kingdom
SE1 9NH |
| Contact telephone | +44 (0)20 7848 4270 |
| Contact fax | +44 (0)20 7848 4185 |
| Contact email | maria.pufulete@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN43577261 |
| Date last extracted from ISRCTN register | 17/04/2008 |
