Condition category
Cancer
Date applied
04/08/2006
Date assigned
06/10/2006
Last edited
10/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.kcl.ac.uk

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

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes