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ISRCTN
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ISRCTN43577261
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ClinicalTrials.gov identifier
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Public title
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The influence of methylenetetrahydrofolate reductase C677T genotype and folate status on deoxyribonucleic acid methylation and uracil misincorporation in the colon of healthy volunteers
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Scientific title
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Acronym
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FolGene
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Serial number at source
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JQADGAR
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Study hypothesis
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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.
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Ethics approval
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King's College Hospital Research Ethics Committee approval received 13 July 2006 (reference Number 06/Q0703/29).
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Study design
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Randomised, double blind, placebo controlled, parallel study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Colorectal cancer
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Participants - inclusion criteria
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No lesions detected on full colonoscopy
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Participants - exclusion criteria
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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
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Anticipated start date
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11/09/2006
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Anticipated end date
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11/09/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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400 µg per day folic acid or placebo for three months.
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Primary outcome measure(s)
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Changes in genomic and gene specific DNA methylation and uracil misincorporation.
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Secondary outcome measure(s)
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Changes in blood and tissue folate and plasma homocysteine.
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Sources of funding
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Biotechnology and Biological Sciences Research Council (BBSRC) (reference number: BB/D523178/1)
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Trial website
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Publications
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Contact name
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Dr
Maria
Pufulete
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Address
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King's College London
Franklin-Wilkins Building
150 Stamford Street
Waterloo
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Tel
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+44 (0)20 7848 4270
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Fax
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+44 (0)20 7848 4185
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Email
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maria.pufulete@kcl.ac.uk
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Sponsor
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Nutritional Sciences Research Division (UK)
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Address
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King's College London
Hodkin Building
Guy's Campus
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Sponsor website:
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http://www.kcl.ac.uk
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Date applied
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04/08/2006
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Last edited
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06/10/2006
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Date ISRCTN assigned
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06/10/2006
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