NCT00479479

Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 4 Weeks – 4 Months
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Vitamin B 12 Deficiency

Interventions

Type	Name	Description
DRUG	Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)	an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-08-01
• Completion: 2006-12-01
• First posted: 2007-05-28
• Last updated: 2015-07-21

Locations

1 site across 1 country: Norway