Cobalamin Status in Young Children With Developmental Delay - Full Text View

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:	NCT00710138

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 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.

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 Developmental Delay and Regression

Resource links provided by NLM:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: B Vitamins

Drug Information available for: Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

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, neurological evaluation and growth parameters [ Time Frame: Reevalutation after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maternal evaluation of infant behaviour [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 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: 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

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: developmental delay and regression and other vague neurological symptoms

Exclusion Criteria:

Children with syndromic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710138

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:

Bjorke 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.

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.

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.

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.

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

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.

Responsible Party:	Anne-Lise Bjørke Monsen, Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00710138 History of Changes
Other Study ID Numbers:	19072
Study First Received:	July 2, 2008
Last Updated:	August 13, 2010
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services; Norway: Norwegian Institute of Public Health

Keywords provided by Haukeland University Hospital:

Cobalamin deficiency
Infant
Nutrition

Cobalamin supplementation
Neurodevelopment
Neurological symptoms

Additional relevant MeSH terms:

Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012