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| Name | Class |
|---|---|
| Norwegian Foundation for Health and Rehabilitation | OTHER |
| Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) | Dietary Supplement | 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters | Reevalutation after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal evaluation of infant behaviour | After 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Haukeland University Hospital | Bergen | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11533328 | Background | 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. | |
| 1432418 | 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. |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D006879 | Hydroxocobalamin |
| D014805 | Vitamin B 12 |
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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|
| 16310594 | 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. |
| 8990052 | 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. |
| 9930566 | Background | Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. |
| 18595990 | 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. |
| 24025626 | Derived | 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |