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Cobalamin Status in Young Children With Developmental Delay

NCT00710138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-08-16

No results posted yet for this study

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.

Conditions

  • Vitamin B 12 Deficiency

Interventions

DIETARY_SUPPLEMENT

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

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

Sponsors & Collaborators

  • Norwegian Foundation for Health and Rehabilitation

    collaborator OTHER

  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Anne-Lise Bjørke Monsen, M.D., Ph.D. · Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway

  • Per Magne Ueland, M.D., Ph.D. · Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00710138 on ClinicalTrials.gov