Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development
|First Received Date ICMJE||May 25, 2007|
|Last Updated Date||May 25, 2007|
|Start Date ICMJE||December 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Outcome is related to changes in growth parameters; weight, length, head circumference [ Time Frame: Infant age: 6 weeks - 4 months ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development|
|Official Title ICMJE||Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development|
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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Condition ICMJE||Vitamin B 12 Deficiency|
|Intervention ICMJE||Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 4 Months|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Norway|
|NCT Number ICMJE||NCT00479479|
|Other Study ID Numbers ICMJE||16941|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Haukeland University Hospital|
|Information Provided By||Haukeland University Hospital|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP