Cobalamin Status in Young Children With Developmental Delay

Vitamin B 12 Deficiency Clinical Trial

Official title:

Cobalamin Status in Young Children With Developmental Delay and Regression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710138
• Other study ID #: 19072
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: August 13, 2010
• Start date: June 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 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.

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: developmental delay and regression and other vague neurological 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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

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 (6)

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

Casella EB, Valente M, de Navarro JM, Kok F. Vitamin B12 deficiency in infancy as a cause of developmental regression. Brain Dev. 2005 Dec;27(8):592-4. — View Citation

Graham SM, Arvela OM, Wise GA. Long-term neurologic consequences of nutritional vitamin B12 deficiency in infants. J Pediatr. 1992 Nov;121(5 Pt 1):710-4. — View Citation

Grattan-Smith PJ, Wilcken B, Procopis PG, Wise GA. The neurological syndrome of infantile cobalamin deficiency: developmental regression and involuntary movements. Mov Disord. 1997 Jan;12(1):39-46. — 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

Outcome

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