Vitamin B 12 Deficiency
Conditions
Keywords
Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Neurodevelopment, Neurological symptoms
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.
Interventions
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters | Reevalutation after 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maternal evaluation of infant behaviour | After 4 weeks |
Countries
Norway