Cobalamin Status in Young Children With Developmental Delay

NCT00710138 | Completed

• 1 other identifier: 19072
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vitamin B 12 Deficiency

Keywords

Cobalamin deficiency; Infant; Nutrition; Cobalamin supplementation; Neurodevelopment; Neurological symptoms

Outcome Measures

Primary Outcomes (1)

• Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters

  Reevalutation after 4 weeks

Secondary Outcomes (1)

• Maternal evaluation of infant behaviour

  After 4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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)

2

SHAM COMPARATOR

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)

Interventions

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) DIETARY_SUPPLEMENT

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

Also known as: Vitamin B12, Cobalamin, B vitamins

1; 2

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children below 8 months of age
• Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms

You may not qualify if:

• Children with syndromic disease

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Norwegian Foundation for Health and Rehabilitation: collaborator
• Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway: collaborator

Study Sites (1)

Department of Pediatrics, Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (7)

• 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. doi: 10.1542/peds.108.3.624.

  PMID: 11533328 BACKGROUND

• 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. doi: 10.1016/s0022-3476(05)81897-9.

  PMID: 1432418 BACKGROUND

• 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. doi: 10.1016/j.braindev.2005.02.005.

  PMID: 16310594 BACKGROUND

• 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. doi: 10.1002/mds.870120108.

  PMID: 8990052 BACKGROUND

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

  PMID: 9930566 BACKGROUND

• Bjorke-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.

  PMID: 18595990 BACKGROUND

• Torsvik I, Ueland PM, Markestad T, Bjorke-Monsen AL. Cobalamin supplementation improves motor development and regurgitations in infants: results from a randomized intervention study. Am J Clin Nutr. 2013 Nov;98(5):1233-40. doi: 10.3945/ajcn.113.061549. Epub 2013 Sep 11.

  PMID: 24025626 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Neurologic Manifestations

Interventions

Hydroxocobalamin; Vitamin B 12; Vitamin B Complex

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anne-Lise Bjørke Monsen, M.D., Ph.D.

  Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway

  PRINCIPAL INVESTIGATOR

• Per Magne Ueland, M.D., Ph.D.

  Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

NO (1)