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 |
| Protocol serial number | JQADGAR |
| Sponsor | King's College London Nutritional Sciences Research Division |
| Funder | Biotechnology and Biological Sciences Research Council (BBSRC) (reference number: BB/D523178/1) |
- Submission date
- 04/08/2006
- Registration date
- 06/10/2006
- Last edited
- 16/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maria Pufulete
Scientific
Scientific
King's College London
Franklin-Wilkins Building
150 Stamford Street
Waterloo
London
SE1 9NH
United Kingdom
| Phone | +44 (0)20 7848 4270 |
|---|---|
| maria.pufulete@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, parallel study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Folic acid |
| Primary outcome measure(s) |
Changes in genomic and gene specific DNA methylation and uracil misincorporation. |
| Key secondary outcome measure(s) |
Changes in blood and tissue folate and plasma homocysteine. |
| Completion date | 11/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College London
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/01/2020: Internal review.
