CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 target
Drug / intervention
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)dietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00710138
NCT00710138N/ACompleted

Cobalamin Status in Young Children With Developmental Delay and Regression

Haukeland University Hospital·interventional·Posted Jul 4, 2008·Updated Aug 16, 2010

In Brief

A clinical study evaluating Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) for Vitamin B 12 Deficiency. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2008
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.0 years ago

Interventions

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)dietary

400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection