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Completed

NCT Number: NCT01105351

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

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%.

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Key information

Conditions

the Effect of MTHFR C677T on Folate Metabolism

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saarland

Homburg, Saarland, 66424, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

folic acid plus B6 and B12

Dietary Supplement

folic acid 400 µg plus vitamin B12 plus B6

Other names: no further names

Folic Acid

Dietary Supplement

folic acid 400 µg

Other names: folic acid alone

Primary outcomes

  1. blood metabolic markers

    Time frame: 18 months

    we will measure primary folate forms after folic acid supplement

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 16, 2010
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.