An interventional study of Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) in Vitamin B 12 Deficiency, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged Up to 8 Months. Per ClinicalTrials.gov, last updated 2010-08-16.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment
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.
72 studies on the registry are indexed under Vitamin B 12 Deficiency; 10 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 44 interventional studies indexed under Vitamin B 12 Deficiency.
Browse Vitamin B 12 Deficiency studies →Haukeland University Hospital is the lead sponsor of 276 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) given as a single intramuscular injection. The syringe is covered so it is impossible to see whether or not it contains any substance.
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance.
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Also known as: Vitamin B12, Cobalamin, B vitamins
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation
Time frame: Reevalutation after 4 weeks
Maternal evaluation of changes in infant behaviour and symptoms
Time frame: After 4 weeks
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Haukeland University Hospital