Cobalamin Status in Young Children With Developmental Delay

Haukeland University Hospital

Status: Completed

Conditions: Vitamin B 12 Deficiency

Treatments: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

Study type: Interventional

Funder types: Other

Identifiers

NCT00710138

19072

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 8 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

2

Sham Comparator group

Description:

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.

Treatment:

Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)