Clinical trial NCT00710138: Cobalamin Status in Young Children With Developmental Delay
Official title: Cobalamin Status in Young Children With Developmental Delay and Regression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B 12 Deficiency
Keywords: Cobalamin deficiency
Infant
Nutrition
Cobalamin supplementation
Neurodevelopment
Neurological symptoms
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Foundation for Health and Rehabilitation
name: Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
First posted: 2008-07-04
Enrollment: 100
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters
timeFrame: Reevalutation after 4 weeks
Secondary outcomes:
measure: Maternal evaluation of infant behaviour
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Pediatrics, Haukeland University Hospital
Study officials:
affiliation: Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
name: Anne-Lise Bjørke Monsen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
name: Per Magne Ueland, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
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.
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.