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...

Date First Received: May 25, 2007

Last Updated: May 25, 2007

Verified by: Haukeland University Hospital, May 2007

Clinical Trial Phase: N/A | Start Date: December 2004

Overall Status: Completed

Estimated Enrollment: 107

Brief Summary

Official Title: “Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

Outcome Measures for this Clinical Trial

Primary Measures

  • 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

Secondary Measures

  • Outcome is related to changes in growth parameters; weight, length, head circumference
    • Time Frame: Infant age: 6 weeks - 4 months

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 4 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Haukeland University Hospital

Overall Clinical Trial Officials and Contacts

Anne-Lise Bjørke Monsen, M.D., Ph.D. Principal Investigator Haukeland University Hospital  

Related Publications

References

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.

Additional Information

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00479479

Study ID Number: 16941

ClinicalTrials.gov Identifier: NCT00479479

Health Authority: Norway: Norwegian Social Science Data Services

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