Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
|ClinicalTrials.gov Identifier: NCT00479479|
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : July 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Vitamin B 12 Deficiency||Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||December 2006|
An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
No Intervention: No intervention
- Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA [ Time Frame: Infant age 6 weeks - 4 months ]
- Outcome is related to changes in growth parameters; weight, length, head circumference [ Time Frame: Infant age: 6 weeks - 4 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479479
|Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital|
|Bergen, Norway, 5018|
|Principal Investigator:||Anne-Lise Bjørke Monsen, M.D., Ph.D.||Haukeland University Hospital|