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

Vitamin B 12 Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479479
• Other study ID #: 16941
• Status: Completed
• Phase: N/A
• First received: May 25, 2007
• Last updated: July 20, 2015
• Start date: December 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2015
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Drug:
• Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)

Locations

Country	Name	City	State
Norway	Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway, Norwegian Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. Review. — View Citation

Bjørke 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. — View Citation

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. — View Citation

Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA		Infant age 6 weeks - 4 months
Secondary	Outcome is related to changes in growth parameters; weight, length, head circumference		Infant age: 6 weeks - 4 months