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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
  Purpose

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%.


Condition Intervention
the Effect of MTHFR C677T on Folate Metabolism
 Dietary Supplement: folic acid plus B6 and B12
Dietary Supplement: folic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Saarland University:

Primary Outcome Measures:
  • blood metabolic markers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    we will measure primary folate forms after folic acid supplement


Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: folic acid plus B6 and B12
folic 400 µg plus vitamin B12 plus B6
 Dietary Supplement: folic acid plus B6 and B12
folic acid 400 µg plus vitamin B12 plus B6
Other Name: no further names
Placebo Comparator: Folic acid
folic acid alone
 Dietary Supplement: folic acid
folic acid 400 µg
Other Name: folic acid alone

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105351

Contacts
Contact: Rima Obeid, PhD 004968411630711 rima.obeid@uks.eu
Contact: Rudolf Eckert, PhD 004968 94108451 Dr.R.Eckert@kkh-geriatrie-igb.de

Locations
Germany
University of Saarland Recruiting
Homburg, Saarland, Germany, 66424
Contact: rima obeid            
Sponsors and Collaborators
Saarland University
Investigators
Principal Investigator: Rima Obeid, PhD Department of Clinical Chemistry, University of Saarland
  More Information

No publications provided

Responsible Party: rima obeid, Prof. Dr., Saarland University
ClinicalTrials.gov Identifier: NCT01105351     History of Changes
Other Study ID Numbers: Folate Forms MTHFR
Study First Received: April 15, 2010
Last Updated: June 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Saarland University:
Folate
MTHFR
Homocysteine

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013