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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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