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

This study has been completed.
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00479479
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

May 25, 2007
May 25, 2007
December 2004
Not Provided
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 ]
Same as current
No Changes Posted
Outcome is related to changes in growth parameters; weight, length, head circumference [ Time Frame: Infant age: 6 weeks - 4 months ]
Same as current
Not Provided
Not Provided
 
Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Vitamin B 12 Deficiency
Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
December 2006
Not Provided

Inclusion Criteria:

  • 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 medications
  • The mother should have an ordinary omnivorous diet

Exclusion Criteria:

  • If there are evidence of serious infant disease during the study period, the infant should be excluded from the study
Both
up to 4 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00479479
16941
No
Not Provided
Haukeland University Hospital
  • Norwegian Foundation for Health and Rehabilitation
  • Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Principal Investigator: Anne-Lise Bjørke Monsen, M.D., Ph.D. Haukeland University Hospital
Haukeland University Hospital
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP