Vitamin B 12 Deficiency
Conditions
Keywords
Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Feeding problems, Gastrointestinal 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 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.
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: feeding problems and/or gastrointestinal 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, growth parameters, symptom and neurological evaluation | Reevalutation after 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maternal evaluation of changes in infant behaviour and symptoms | After 4 weeks |
Countries
Norway