Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-10 @ 6:48 AM
Study NCT ID:
NCT00710359
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006879', 'term': 'Hydroxocobalamin'}, {'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D014803', 'term': 'Vitamin B Complex'}], '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'}, {'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation', 'timeFrame': 'Reevalutation after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Maternal evaluation of changes in infant behaviour and symptoms', 'timeFrame': 'After 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cobalamin deficiency', 'Infant', 'Nutrition', 'Cobalamin supplementation', 'Feeding problems', 'Gastrointestinal symptoms'], 'conditions': ['Vitamin B 12 Deficiency']}, 'referencesModule': {'references': [{'pmid': '9930566', 'type': 'BACKGROUND', 'citation': 'Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.'}, {'pmid': '11533328', 'type': 'BACKGROUND', 'citation': 'Bjorke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. doi: 10.1542/peds.108.3.624.'}, {'pmid': '8166372', 'type': 'BACKGROUND', 'citation': 'Wulffraat NM, De Schryver J, Bruin M, Pinxteren-Nagler E, van Dijken PJ. Failure to thrive is an early symptom of the imerslund Grasbeck syndrome. Am J Pediatr Hematol Oncol. 1994 May;16(2):177-80.'}, {'pmid': '14633879', 'type': 'BACKGROUND', 'citation': 'Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75. doi: 10.1373/clinchem.2003.019869.'}, {'pmid': '18595990', 'type': 'BACKGROUND', 'citation': 'Bjorke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.'}, {'pmid': '24025626', 'type': 'DERIVED', 'citation': 'Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.\n\nIn this study we want to establish the prevalence of cobalamin deficiency in infants with gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.\n\nStudy hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children below 8 months of age\n* Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms\n\nExclusion Criteria:\n\n* Children with syndromic disease'}, 'identificationModule': {'nctId': 'NCT00710359', 'briefTitle': 'Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems', 'organization': {'class': 'OTHER', 'fullName': 'Haukeland University Hospital'}, 'officialTitle': 'Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems', 'orgStudyIdInfo': {'id': '19157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) given as a single intramuscular injection. The syringe is covered so it is impossible to see whether or not it contains any substance.', 'interventionNames': ['Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance.', 'interventionNames': ['Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)']}], 'interventions': [{'name': 'Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin B12', 'Cobalamin', 'B vitamins'], 'description': '400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Pediatrics, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Anne-Lise Bjørke Monsen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway'}, {'name': 'Per Magne Ueland, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haukeland University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Foundation for Health and Rehabilitation', 'class': 'OTHER'}, {'name': 'Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Anne-Lise Bjørke Monsen', 'oldOrganization': 'Haukeland University Hospital'}}}}