Contact information
Type
Scientific
Primary contact
Dr Maria Pufulete
ORCID ID
Contact details
King's College London
Franklin-Wilkins Building
150 Stamford Street
Waterloo
London
SE1 9NH
United Kingdom
+44 (0)20 7848 4270
maria.pufulete@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
JQADGAR
Study information
Scientific title
Acronym
FolGene
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.
Ethics approval
King's College Hospital Research Ethics Committee, 13/07/2006, ref: 06/Q0703/29
Study design
Randomised, double blind, placebo controlled, parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colorectal cancer
Intervention
400 µg per day folic acid or placebo for three months.
Intervention type
Drug
Phase
Not Specified
Drug names
Folic acid
Primary outcome measures
Changes in genomic and gene specific DNA methylation and uracil misincorporation.
Secondary outcome measures
Changes in blood and tissue folate and plasma homocysteine.
Overall trial start date
11/09/2006
Overall trial end date
11/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
No lesions detected on full colonoscopy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
11/09/2006
Recruitment end date
11/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 9NH
United Kingdom
Sponsor information
Organisation
Nutritional Sciences Research Division (UK)
Sponsor details
King's College London
Hodkin Building
Guy's Campus
London
SE1 1UL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Biotechnology and Biological Sciences Research Council (BBSRC) (reference number: BB/D523178/1)
Alternative name(s)
BBSRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24108782
Publication citations
-
Results
Hanks J, Ayed I, Kukreja N, Rogers C, Harris J, Gheorghiu A, Liu CL, Emery P, Pufulete M, The association between MTHFR 677C>T genotype and folate status and genomic and gene-specific DNA methylation in the colon of individuals without colorectal neoplasia., Am. J. Clin. Nutr., 2013, 98, 6, 1564-1574, doi: 10.3945/ajcn.113.061432.