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CompletedNCT05315843Cbl_NeoUpdated Apr 13, 2025

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

An observational study in Vitamin B 12 Deficiency, sponsored by University Children's Hospital, Zurich. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by University Children's Hospital, Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Sex
All
01

Study summary

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).

02

Conditions studied

  • Vitamin B 12 Deficiency
03

In context

Vitamin B 12 Deficiency

72 studies on the registry are indexed under Vitamin B 12 Deficiency; 10 are open to participants now.

This study's enrollment of 160 is below the median of 200 across 28 observational studies indexed under Vitamin B 12 Deficiency.

Browse Vitamin B 12 Deficiency studies →

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pregnant females and their children

Inclusion criteria

  • Pregnant women
  • their newborns

Exclusion criteria

Exclusion Criteria:

  • children: preterm birth
  • children: neonatal disease
  • women: disease around birth
  • women: multiples pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Homocysteine

    Plasma total Homocysteine higher in B12 deficient children

    Time frame: 9 months

07

Study locations

2 sites
  • LKH Bregenz
    Bregenz, 6900, Austria
  • University Childrens Hospital Freiburg
    Freiburg, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05315843
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Nov 7, 2022
Primary completion
Jul 15, 2024
Completion
Dec 31, 2024
Last update
Apr 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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