Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-20 @ 1:45 AM
Study NCT ID:
NCT00111267
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2005-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 165}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2005-05-18', 'studyFirstSubmitQcDate': '2005-05-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive performance in the domains of attention, concentration, memory, executive function, speed'}], 'secondaryOutcomes': [{'measure': 'Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate'}]}, 'conditionsModule': {'keywords': ['vitamin B12', 'cognitive function', 'oral supplementation', 'elderly'], 'conditions': ['Cognitive Decline', 'Cognitive Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.', 'detailedDescription': 'Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment.\n\nWe investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild vitamin B12 deficiency:\n\n * Low plasma vitamin B12 concentration (100 \\< B12 \\< 300 pmol/L)\n * Elevated methylmalonic acid (MMA) concentration (\\> 0.32 umol/L)\n * Creatinine concentration \\< 120 umol/L\n\nExclusion Criteria:\n\n* Severe cognitive impairment\n* Anemia\n* Gastrointestinal surgery or diseases\n* Use of vitamin B12 injections or supplements containing \\> 25 ug vitamin B12 and/or 200 ug folic acid\n* \\< 90% compliance during a 2 week placebo run in period\n* No written informed consent\n* Participation in other research studies'}, 'identificationModule': {'nctId': 'NCT00111267', 'briefTitle': 'Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study', 'orgStudyIdInfo': {'id': 'P03.0277L'}, 'secondaryIdInfos': [{'id': 'ZonMW 2100.0067'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'vitamin B12 supplementation', 'type': 'BEHAVIORAL'}, {'name': 'vitamin B12 + folic acid combined supplementation', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700 EV', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}]}}}