Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development
Information source: Haukeland University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B 12 Deficiency
Intervention: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) (Drug)
Sponsored by: Haukeland University Hospital
Official(s) and/or principal investigator(s):
Anne-Lise Bjørke Monsen, M.D., Ph.D., Principal Investigator, Affiliation: Haukeland University Hospital
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
The purpose of this study is to determine if cobalamin supplementation may influence the
metabolic profile related to cobalamin status in infants.
Official title: Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development
Study design: Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA
Secondary outcome: Outcome is related to changes in growth parameters; weight, length, head circumference
During fetal life and infancy, an adequate cobalamin status is important for normal growth
and central nervous system development. A metabolic profile consistent with impaired
cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature
organ systems or cobalamin deficiency has not been clarified.
Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or
methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.
The purpose of this randomized, controlled study is to determine if cobalamin supplementation
may influence the metabolic profile related to cobalamin status in infants.
Six weeks old infants will be randomly assigned to receive either an intramuscular injection
with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum,
and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be
determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal
nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco
will be completed.
Minimum age: N/A.
Maximum age: 4 Months.
- 6 weeks old infants
- The infant should be healthy and not have any serious malformations
- The mother should be healthy and not have any serious disorders or use any daily
- The mother should have an ordinary omnivorous diet
- If there are evidence of serious infant disease during the study period, the infant
should be excluded from the study
Locations and Contacts
Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital, Bergen 5018, Norway
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.
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.
Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. Review.
Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. Review.
Starting date: December 2004
Ending date: December 2006
Last updated: May 25, 2007