The influence of methylenetetrahydrofolate reductase C677T genotype and folate status on deoxyribonucleic acid methylation and uracil misincorporation in the colon of healthy volunteers

ISRCTN	ISRCTN43577261
DOI	https://doi.org/10.1186/ISRCTN43577261
Secondary identifying numbers	JQADGAR

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Maria Pufulete
Scientific

King's College London
Franklin-Wilkins Building
150 Stamford Street
Waterloo
London
SE1 9NH
United Kingdom

Phone	+44 (0)20 7848 4270
Email	maria.pufulete@kcl.ac.uk

Study design	Randomised, double blind, placebo controlled, parallel study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The influence of methylenetetrahydrofolate reductase C677T genotype and folate status on deoxyribonucleic acid methylation and uracil misincorporation in the colon of healthy volunteers
Study acronym	FolGene
Study objectives	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(s)	King's College Hospital Research Ethics Committee, 13/07/2006, ref: 06/Q0703/29
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	400 µg per day folic acid or placebo for three months.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Folic acid
Primary outcome measure	Changes in genomic and gene specific DNA methylation and uracil misincorporation.
Secondary outcome measures	Changes in blood and tissue folate and plasma homocysteine.
Overall study start date	11/09/2006
Completion date	11/09/2009

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	60
Key inclusion criteria	No lesions detected on full colonoscopy
Key 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
Date of first enrolment	11/09/2006
Date of final enrolment	11/09/2009

King's College London

London
SE1 9NH
United Kingdom

King's College London Nutritional Sciences Research Division
University/education

Hodgkin Building
Guy's Campus
London
SE1 1UL
England
United Kingdom

Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Research council

Biotechnology and Biological Sciences Research Council (BBSRC) (reference number: BB/D523178/1)
Government organisation / National government

Alternative name(s): UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location: United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No

16/01/2020: Internal review.