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

Universität des Saarlandes

Status: Completed

Conditions: the Effect of MTHFR C677T on Folate Metabolism

Treatments: Dietary Supplement: folic acid plus B6 and B12; Dietary Supplement: folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01105351

Folate Forms MTHFR

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

folic acid plus B6 and B12

Active Comparator group

Description:

folic 400 µg plus vitamin B12 plus B6

Treatment:

Dietary Supplement: folic acid plus B6 and B12

Folic acid

Placebo Comparator group

Description:

folic acid alone

Treatment:

Dietary Supplement: folic acid