Cobalamin Status in Young Children With Developmental Delay

Study Overview
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Brief Summary
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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.

Official Title
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Cobalamin Status in Young Children With Developmental Delay and Regression

Conditions
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Vitamin B 12 Deficiency

Intervention / Treatment
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* Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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)<br>* 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection<br>* Other names: B vitamins;|
| Sham Comparator: 2<br>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)<br>* 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection<br>* Other names: B vitamins;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal evaluation of infant behaviour |  | After 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Neurodevelopment, Neurological symptoms