Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-08 @ 6:03 PM
Study NCT ID:
NCT02679833
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2016-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2016-02-08', 'studyFirstSubmitQcDate': '2016-02-09', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in plasma concentrations of methylmalonic acid', 'timeFrame': 'Baseline, 3 months', 'description': 'Lowering methylmalonic acid in the B12 arm compared with the placebo arm'}, {'measure': 'The change in plasma concentrations of holotranscobalamin', 'timeFrame': 'Baseline, 3 months', 'description': 'The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm'}, {'measure': 'The change in plasma concentrations of homocysteine', 'timeFrame': 'Baseline, 3 months', 'description': 'Lowering homocysteine in the B12 arm compared with the placebo arm'}, {'measure': 'The change in plasma concentrations of vitamin B12', 'timeFrame': 'Baseline, 3 months', 'description': 'The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cobalamin biomarkers', 'Anemia', 'Vegan diet', 'Subclinical', 'Metabolic functional markers', 'Holotranscobalamin', 'Methylmalonic acid'], 'conditions': ['Cobalamin Deficiency']}, 'referencesModule': {'references': [{'pmid': '30680547', 'type': 'DERIVED', 'citation': 'Zant A, Awwad HM, Geisel J, Keller M, Obeid R. Vitamin B12-fortified toothpaste improves vitamin status in elderly people: a randomized, double-blind, placebo-controlled study. Aging Clin Exp Res. 2019 Dec;31(12):1817-1825. doi: 10.1007/s40520-019-01125-6. Epub 2019 Jan 24.'}, {'pmid': '28052884', 'type': 'DERIVED', 'citation': 'Siebert AK, Obeid R, Weder S, Awwad HM, Sputtek A, Geisel J, Keller M. Vitamin B-12-fortified toothpaste improves vitamin status in vegans: a 12-wk randomized placebo-controlled study. Am J Clin Nutr. 2017 Mar;105(3):618-625. doi: 10.3945/ajcn.116.141978. Epub 2017 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults: men and women\n* Stable diet for at least 24 months (omnivorous or a vegan diet).\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)\n* Renal diseases\n* Liver diseases\n* Patients with cancer (or cancer history)\n* Pre-study treatment with vitamin B12 or folate'}, 'identificationModule': {'nctId': 'NCT02679833', 'briefTitle': 'Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study', 'orgStudyIdInfo': {'id': 'B12 status after toothpaste'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cyanocobalamin', 'description': 'A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.', 'interventionNames': ['Dietary Supplement: Cyanocobalamin']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Toothpaste not containing the vitamin.', 'armGroupLabels': ['Placebo']}, {'name': 'Cyanocobalamin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Toothpaste containing100 µg cyanocobalamin/g.', 'armGroupLabels': ['Cyanocobalamin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'University of Saarland', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '35444', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Institute of Alternative and Sustainable Nutrition', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Markus Keller, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Alternative and Sustainable Nutrition, Giessen, Germany'}, {'name': 'Rima Obeid, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saarland University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing only between the two responsible study centers in a coded form, where participant ID is not shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Alternative and Sustainable Nutrition (IFANE)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Rima Obeid', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}