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

This study is currently recruiting participants.
Verified June 2012 by Saarland University
Sponsor:
Information provided by (Responsible Party):
rima obeid, Saarland University
ClinicalTrials.gov Identifier:
NCT01105351
First received: April 15, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes

April 15, 2010
June 6, 2012
June 2010
December 2012   (final data collection date for primary outcome measure)
blood metabolic markers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
we will measure primary folate forms after folic acid supplement
Same as current
Complete list of historical versions of study NCT01105351 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

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%.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
the Effect of MTHFR C677T on Folate Metabolism
  • Dietary Supplement: folic acid plus B6 and B12
    folic acid 400 µg plus vitamin B12 plus B6
    Other Name: no further names
  • Dietary Supplement: folic acid
    folic acid 400 µg
    Other Name: folic acid alone
  • Active Comparator: folic acid plus B6 and B12
    folic 400 µg plus vitamin B12 plus B6
    Intervention: Dietary Supplement: folic acid plus B6 and B12
  • Placebo Comparator: Folic acid
    folic acid alone
    Intervention: Dietary Supplement: folic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
Yes
Contact: Rima Obeid, PhD 004968411630711 rima.obeid@uks.eu
Contact: Rudolf Eckert, PhD 004968 94108451 Dr.R.Eckert@kkh-geriatrie-igb.de
Germany
 
NCT01105351
Folate Forms MTHFR
No
rima obeid, Saarland University
Saarland University
Not Provided
Principal Investigator: Rima Obeid, PhD Department of Clinical Chemistry, University of Saarland
Saarland University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP