- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105351
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR
May 7, 2018 updated by: Rima Obeid, Universität des Saarlandes
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%.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saarland
-
Homburg, Saarland, Germany, 66424
- University of Saarland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: folic acid plus B6 and B12
folic 400 µg plus vitamin B12 plus B6
|
folic acid 400 µg plus vitamin B12 plus B6
Other Names:
|
PLACEBO_COMPARATOR: Folic acid
folic acid alone
|
folic acid 400 µg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood metabolic markers
Time Frame: 18 months
|
we will measure primary folate forms after folic acid supplement
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rima Obeid, PhD, Department of Clinical Chemistry, University of Saarland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
April 15, 2010
First Submitted That Met QC Criteria
April 15, 2010
First Posted (ESTIMATE)
April 16, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Folate Forms MTHFR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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