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Cobalamin Status in Young Children With Developmental Delay

Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin B 12 Deficiency

Intervention: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Haukeland University Hospital

Official(s) and/or principal investigator(s):
Anne-Lise Bjørke Monsen, M.D., Ph.D., Principal Investigator, Affiliation: Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
Per Magne Ueland, M.D., Ph.D., Study Director, Affiliation: Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY

Summary

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. 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.

Clinical Details

Official title: Cobalamin Status in Young Children With Developmental Delay and Regression

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters

Secondary outcome: Maternal evaluation of infant behaviour

Eligibility

Minimum age: N/A. Maximum age: 8 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children below 8 months of age

- Clinical diagnosis or symptoms: developmental delay and regression and other vague

neurological symptoms Exclusion Criteria:

- Children with syndromic disease

Locations and Contacts

Department of Pediatrics, Haukeland University Hospital, Bergen 5021, Norway
Additional Information

Related publications:

Bjørke 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. Erratum in: Pediatrics 2002 Oct;110(4):853.

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.

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.

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.

Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. Review.

Bjørke-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.

Starting date: June 2008
Last updated: August 13, 2010

Page last updated: August 23, 2015

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