the Effect of MTHFR C677T on Folate MetabolismNCT01105351
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR
A study testing folic acid plus B6 and B12 and folic acid in people with the Effect of MTHFR C677T on Folate Metabolism, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- the Effect of MTHFR C677T on Folate Metabolism
- What is being tested?
- folic acid plus B6 and B12 and folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males and females
- Age > 65 years.
Who cannot join
- Renal dysfunction
- Recent stroke, or coronary event (within the last 3 months)
- Current cancer treatment
- Antifolate (e.g. methotrexate) treatment
- Ileum resection
- Current B-vitamin supplement
- Epilepsy medications
- Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme
The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.
Read the detailed description
The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.
- Being tested
- folic acid plus B6 and B12, folic acid
- Keywords
- Folate, MTHFR, Homocysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid plus B6 and B12Dietary supplement
Also called no further names
folic acid 400 µg plus vitamin B12 plus B6
folic acidDietary supplement
Also called folic acid alone
folic acid 400 µg
| Study group | Role | What they receive |
|---|---|---|
| folic acid plus B6 and B12 | Active comparator | folic 400 µg plus vitamin B12 plus B6 Receives: Dietary Supplement: folic acid plus B6 and B12 |
| Folic acid | Placebo comparator | folic acid alone Receives: Dietary Supplement: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood metabolic markers
we will measure primary folate forms after folic acid supplement
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for the Effect of MTHFR C677T on Folate MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Obeid, Universität des Saarlandes
- Investigators
- Rima Obeid, PhD, Principal investigator, Department of Clinical Chemistry, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105351
- Sponsor's protocol ID
- Folate Forms MTHFR
- Status last verified
- May 2018
- First submitted
- 15 Apr 2010
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Obeid R, Kirsch SH, Dilmann S, Klein C, Eckert R, Geisel J, Herrmann W. Folic acid causes higher prevalence of detectable unmetabolized folic acid in serum than B-complex: a randomized trial. Eur J Nutr. 2016 Apr;55(3):1021-8. doi: 10.1007/s00394-015-0916-z. Epub 2015 May 6.
PubMed 25943647
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mild Increase in Folic Acid Intake on the Distribution of Folate Forms in Relation to a Common Polymorphism in One Folate Catabolising Enzyme
- ClinicalTrials.gov ID
- NCT01105351
- Acronym / sponsor ID
- Folate Forms MTHFR
- Keywords
- Folate, MTHFR, Homocysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The common polymorphism in MTHFR gene (C677T) has a significant effect on (6S)-5-CH3-H4folate after folic acid supplementation. For example, post supplementation differences in (6S)-5-CH3-H4folate between CC and TT are above 30%.
Detailed description
The investigators aim to test the effect of low doses of folic acid with or without B6 and B12 on folate forms in relation to polymorphisms in folate catabolising enzymes in elderly people. Our hypothesis is that differences in folate forms after folic acid supplementation might be due to polymorphisms in folate catabolising enzymes. Therefore, folic acid might be retained by people with certain genotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| folic acid plus B6 and B12 | Active comparator | Dietary Supplement: folic acid plus B6 and B12folic 400 µg plus vitamin B12 plus B6 |
| Folic acid | Placebo comparator | Dietary Supplement: folic acidfolic acid alone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Males and females
- Age > 65 years.
Key exclusion criteria (8 listed)
- Renal dysfunction
- Recent stroke, or coronary event (within the last 3 months)
- Current cancer treatment
- Antifolate (e.g. methotrexate) treatment
- Ileum resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acid plus B6 and B12Also: no further namesfolic acid 400 µg plus vitamin B12 plus B6 | Dietary supplement | folic acid plus B6 and B12 |
| folic acidAlso: folic acid alonefolic acid 400 µg | Dietary supplement | Folic acid |
Primary outcome
blood metabolic markers
Time frame: 18 months
we will measure primary folate forms after folic acid supplement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Results publication: PubMed 25943647Obeid R, Kirsch SH, Dilmann S, Klein C, Eckert R, Geisel J, Herrmann W. Folic acid causes higher prevalence of detectable unmetabolized folic acid in serum than B-complex: a randomized trial. Eur J Nutr. 2016 Apr;55(3):1021-8. doi: 10.1007/s00394-015-0916-z. Epub 2015 May 6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima Obeid, PhD principal investigator
Department of Clinical Chemistry, University of Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid plus B6 and B12 and folic acid in people with the Effect of MTHFR C677T on Folate Metabolism, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood metabolic markers (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.