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Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01105351
Enrollment
75
Registered
2010-04-16
Start date
2010-06-30
Completion date
2013-12-31
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Effect of MTHFR C677T on Folate Metabolism

Keywords

Folate, MTHFR, Homocysteine

Brief 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%.

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.

Interventions

DIETARY_SUPPLEMENTfolic acid plus B6 and B12

folic acid 400 µg plus vitamin B12 plus B6

DIETARY_SUPPLEMENTfolic acid

folic acid 400 µg

Sponsors

Universität des Saarlandes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Males and females * Age \> 65 years.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
blood metabolic markers18 monthswe will measure primary folate forms after folic acid supplement

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026