NCT00710138

Cobalamin Status in Young Children With Developmental Delay

Cobalamin Status in Young Children With Developmental Delay and Regression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 8 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin B 12 Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)	400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-07-04
• Last updated: 2010-08-16

Locations

1 site across 1 country: Norway