Cobalamin Status in Young Children With Developmental Delay
NCT ID: NCT00710138
Last Updated: 2010-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2008-06-30
2010-08-31
Brief Summary
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In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. 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.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
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.
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
2
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.
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Interventions
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Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms
Exclusion Criteria
8 Months
ALL
No
Sponsors
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Norwegian Foundation for Health and Rehabilitation
OTHER
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Haukeland University Hospital
Principal Investigators
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Anne-Lise Bjørke Monsen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
Per Magne Ueland, M.D., Ph.D.
Role: STUDY_DIRECTOR
Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
Locations
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Department of Pediatrics, Haukeland University Hospital
Bergen, , Norway
Countries
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References
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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.
Graham SM, Arvela OM, Wise GA. Long-term neurologic consequences of nutritional vitamin B12 deficiency in infants. J Pediatr. 1992 Nov;121(5 Pt 1):710-4. doi: 10.1016/s0022-3476(05)81897-9.
Casella EB, Valente M, de Navarro JM, Kok F. Vitamin B12 deficiency in infancy as a cause of developmental regression. Brain Dev. 2005 Dec;27(8):592-4. doi: 10.1016/j.braindev.2005.02.005.
Grattan-Smith PJ, Wilcken B, Procopis PG, Wise GA. The neurological syndrome of infantile cobalamin deficiency: developmental regression and involuntary movements. Mov Disord. 1997 Jan;12(1):39-46. doi: 10.1002/mds.870120108.
Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
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.
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.
Other Identifiers
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19072
Identifier Type: -
Identifier Source: org_study_id
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