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

July 20, 2015 updated by: Haukeland University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5018
        • Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cobalamin
An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
No Intervention: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Infant age 6 weeks - 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 25, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16941

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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