Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
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
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.
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 Gastrointestinal Symptoms or Feeding Problems
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, growth parameters, symptom and neurological evaluation
Secondary outcome: Maternal evaluation of changes in infant behaviour and symptoms
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: feeding problems and/or gastrointestinal symptoms
Exclusion Criteria:
- Children with syndromic disease
Locations and Contacts
Department of Pediatrics, Haukeland University Hospital, Bergen 5021, Norway
Additional Information
Related publications: 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, 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. Wulffraat NM, De Schryver J, Bruin M, Pinxteren-Nagler E, van Dijken PJ. Failure to thrive is an early symptom of the imerslund Gräsbeck syndrome. Am J Pediatr Hematol Oncol. 1994 May;16(2):177-80. 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. 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: April 2008
Last updated: August 13, 2010
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