Cobalamin Supply and Metabolism in Healthy Children From Birth to the Age of 12 Months and in Their Mothers (Cbl_Neo) (Cbl_Neo)

April 9, 2025 updated by: University Children's Hospital, Zurich

Introduction: Infants with severe vitamin B12 (cobalamin, Cbl) deficiency can develop severe, sometimes irreparable neurological damage in the first months of life. Neonatal Cbl deficiency is usually secondary and due to low maternal Cbl stores, e.g. in vegan diets or pernicious anaemia. This Cbl deficiency is then often also found in breast milk. In the Austrian newborn screening (NBS) for congenital diseases of the Cbl metabolism, newborns with secondary Cbl deficiency are also frequently discovered. For these, the risk-benefit assessment of the invasive work-up and treatment that follows is complex. Little is known about how Cbl levels in maternal blood relate to those in breast milk and the corresponding levels in the child.

Objective: To investigate the effects of maternal nutrition and maternal Cbl status on neonatal Cbl levels. In the breastfeeding period, the effects of maternal nutrition on breast milk and infant Cbl status will be investigated, as well as their relationship to the maternal and infant microbiome. We hypothesise that adequate Cbl supply in early life is not determined by diet alone, but also by the interactions between diet and microbiome.

Design and methods: Prospective cohort studies of 100 women and their children with measurement of Cbl, methylmalonic acid, homocysteine and other metabolites of Cbl metabolism in umbilical cord blood, maternal blood, dried blood spots and urine from the child at birth. The same parameters are measured in the mother's blood and breast milk after 3 and 9 months; in the child, only measurements of methylmalonic acid in the urine are carried out. A 3-day dietary record is taken from the mother at all measurement times, and from the child at the measurement times of 3 and 9 months. Stool is collected from mother and child at all measurement time points to examine the microbiome relevant to Cbl metabolism. A child development interview will be conducted with mothers by telephone at 12 months of age of their child.

Schedule: The study lasts 2 years with pre- and post-processing. The LKH Bregenz has about 1200 births per year. Assuming a willingness to participate in the study and an enrolment rate of about 20% of the women, a recruitment period of 6 months is planned (enrolment of first participant day 1, last participant end of study month 6; last laboratory parameter measurement end of study month 15; last child development interview study month 18).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

160

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

  • Austria
      • Bregenz, Austria, 6900
        • LKH Bregenz
  • Germany
      • Freiburg, Germany
        • University Childrens Hospital Freiburg

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pregnant females and their children

Description

Inclusion Criteria:

  • Pregnant women
  • their newborns

Exclusion Criteria:

  • children: preterm birth
  • children: neonatal disease
  • women: disease around birth
  • women: multiples pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homocysteine
Time Frame: 9 months
Plasma total Homocysteine higher in B12 deficient children
9 months

Collaborators and Investigators

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

Sponsor

University Children's Hospital, Zurich

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 (Actual)

November 7, 2022

Primary Completion (Actual)

July 15, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cbl_Neo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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