Cobalamin Status in Young Children With Developmental Delay

This study has been completed.
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00710138
First received: July 2, 2008
Last updated: August 13, 2010
Last verified: August 2010

July 2, 2008
August 13, 2010
June 2008
August 2010   (final data collection date for primary outcome measure)
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters [ Time Frame: Reevalutation after 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00710138 on ClinicalTrials.gov Archive Site
Maternal evaluation of infant behaviour [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cobalamin Status in Young Children With Developmental Delay
Cobalamin Status in Young Children With Developmental Delay and Regression

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vitamin B 12 Deficiency
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Other Names:
  • Vitamin B12
  • Cobalamin
  • B vitamins
  • Active Comparator: 1
    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.
    Intervention: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
  • Sham Comparator: 2
    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.
    Intervention: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
up to 8 Months
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00710138
19072
No
Anne-Lise Bjørke Monsen, Haukeland University Hospital
Haukeland University Hospital
  • Norwegian Foundation for Health and Rehabilitation
  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Principal Investigator: Anne-Lise Bjørke Monsen, M.D., Ph.D. Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
Study Director: Per Magne Ueland, M.D., Ph.D. Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
Haukeland University Hospital
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP