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Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems

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ClinicalTrials.gov Identifier: NCT00710359
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : August 16, 2010
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

Tracking Information
First Submitted Date  ICMJE July 2, 2008
First Posted Date  ICMJE July 4, 2008
Last Update Posted Date August 16, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation [ Time Frame: Reevalutation after 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00710359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2008)
Maternal evaluation of changes in infant behaviour and symptoms [ Time Frame: After 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Official Title  ICMJE Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Brief 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 gastrointestinal symptoms and/or feeding problems. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vitamin B 12 Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 3, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children below 8 months of age
  • Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms

Exclusion Criteria:

  • Children with syndromic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00710359
Other Study ID Numbers  ICMJE 19157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne-Lise Bjørke Monsen, Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE
  • Norwegian Foundation for Health and Rehabilitation
  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Investigators  ICMJE
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
PRS Account Haukeland University Hospital
Verification Date August 2010

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