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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00710359
Other study ID # 19157
Secondary ID
Status Completed
Phase N/A
First received July 2, 2008
Last updated August 13, 2010
Start date April 2008
Est. completion date August 2010

Study information

Verified date August 2010
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Norwegian Institute of Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 8 Months
Eligibility Inclusion Criteria:

- Children below 8 months of age

- Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms

Exclusion Criteria:

- Children with syndromic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Norway Department of Pediatrics, Haukeland University Hospital Bergen

Sponsors (3)

Lead Sponsor Collaborator
Haukeland University Hospital Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway, Norwegian Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Bjørke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. Erratum in: Pediatrics 2002 Oct;110(4):853. — View Citation

Bjørke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716. — View Citation

Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75. — View Citation

Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. Review. — View Citation

Wulffraat NM, De Schryver J, Bruin M, Pinxteren-Nagler E, van Dijken PJ. Failure to thrive is an early symptom of the imerslund Gräsbeck syndrome. Am J Pediatr Hematol Oncol. 1994 May;16(2):177-80. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation Reevalutation after 4 weeks No
Secondary Maternal evaluation of changes in infant behaviour and symptoms After 4 weeks No
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