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

Not Applicable

Completed

• Conditions: Vitamin B 12 Deficiency
• Interventions: Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

• Registration Number: NCT00479479
• Lead Sponsor: Haukeland University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-08
• Study Completion: 2006-12
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cobalamin	Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)	An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)

Primary Outcome Measures

Name	Time	Method
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 Measures

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

Trial Locations

Locations (1)

Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital; 🇳🇴 Bergen, Norway