Trial record 6 of 69 for:
vitamin B12 deficiency
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
This study has been completed.
Sponsor:
Haukeland University Hospital
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:
NCT00710359
First received: July 2, 2008
Last updated: August 13, 2010
Last verified: August 2010
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Purpose
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 | Intervention |
|---|---|
|
Vitamin B 12 Deficiency |
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems |
Resource links provided by NLM:
Further study details as provided by Haukeland University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maternal evaluation of changes in infant behaviour and symptoms [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | up to 8 Months |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Publications:
| Responsible Party: | Anne-Lise Bjørke Monsen, Haukeland University Hospital |
| ClinicalTrials.gov Identifier: | NCT00710359 History of Changes |
| Other Study ID Numbers: | 19157 |
| Study First Received: | July 2, 2008 |
| Last Updated: | August 13, 2010 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services Norway: Norwegian Institute of Public Health |
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 Hydroxocobalamin Vitamin B 12 Vitamin B Complex Vitamins Gastrointestinal Diseases Signs and Symptoms, Digestive Avitaminosis Malnutrition |
Nutrition Disorders Digestive System Diseases Signs and Symptoms Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013