Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01105351
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2010-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood metabolic markers', 'timeFrame': '18 months', 'description': 'we will measure primary folate forms after folic acid supplement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Folate', 'MTHFR', 'Homocysteine'], 'conditions': ['the Effect of MTHFR C677T on Folate Metabolism']}, 'referencesModule': {'references': [{'pmid': '25943647', 'type': 'RESULT', 'citation': 'Obeid R, Kirsch SH, Dilmann S, Klein C, Eckert R, Geisel J, Herrmann W. Folic acid causes higher prevalence of detectable unmetabolized folic acid in serum than B-complex: a randomized trial. Eur J Nutr. 2016 Apr;55(3):1021-8. doi: 10.1007/s00394-015-0916-z. Epub 2015 May 6.'}]}, 'descriptionModule': {'briefSummary': '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%.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females\n* Age \\> 65 years.\n\nExclusion Criteria:\n\n* Renal dysfunction\n* Recent stroke, or coronary event (within the last 3 months)\n* Current cancer treatment\n* Antifolate (e.g. methotrexate) treatment\n* Ileum resection\n* Current B-vitamin supplement\n* Epilepsy medications\n* Megaloblastic anemia or other indications for treatment with high doses of folate or vitamin B12.'}, 'identificationModule': {'nctId': 'NCT01105351', 'briefTitle': 'Effect of Folic Acid on Primary Folate Forms in Relation to MTHFR', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Folate Forms MTHFR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'folic acid plus B6 and B12', 'description': 'folic 400 µg plus vitamin B12 plus B6', 'interventionNames': ['Dietary Supplement: folic acid plus B6 and B12']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Folic acid', 'description': 'folic acid alone', 'interventionNames': ['Dietary Supplement: folic acid']}], 'interventions': [{'name': 'folic acid plus B6 and B12', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['no further names'], 'description': 'folic acid 400 µg plus vitamin B12 plus B6', 'armGroupLabels': ['folic acid plus B6 and B12']}, {'name': 'folic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['folic acid alone'], 'description': 'folic acid 400 µg', 'armGroupLabels': ['Folic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66424', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'University of Saarland', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Rima Obeid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Chemistry, University of Saarland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Rima Obeid', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}