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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

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.


Condition or disease Intervention/treatment
Vitamin B 12 Deficiency Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Study Start Date : April 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Arm Intervention/treatment
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.
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
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.
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Maternal evaluation of changes in infant behaviour and symptoms [ Time Frame: After 4 weeks ]


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Ages Eligible for Study:   up to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children with syndromic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710359


Locations
Norway
Department of Pediatrics, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Investigators
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne-Lise Bjørke Monsen, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00710359     History of Changes
Other Study ID Numbers: 19157
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by Haukeland University Hospital:
Cobalamin deficiency
Infant
Nutrition
Cobalamin supplementation
Feeding problems
Gastrointestinal symptoms

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Avitaminosis
Malnutrition
Nutrition Disorders
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics