drugset / Trial / NCT00479479
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
Completed
107 enrolled
Haukeland University Hospital
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway · collabNorwegian Foundation for Health and Rehabilitation · collab
RandomizedParallel-groupOpen-labelBasic science
Summary
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life. The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
Timeline
- Start
- 2004-12
- Primary completion
- 2006-08
- Completion
- 2006-12
Publications
- 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.
- Background 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. doi: 10.1373/clinchem.2003.019869.
- Background Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. doi: 10.1007/978-1-4899-2575-6_14.
- Background Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxocobalamin | Unknown | 400 ug | Intramuscular |