ESPED survey Vitamin B12 deficiency in the first year of life

• Conditions: Vitamin B12 deficiency; E53.8; Deficiency of other specified B group vitamins

• Registration Number: DRKS00032822
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-06
• Study Completion: 2024-07-23
• Results First Posted: 2024-07-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

During the study period, newly diagnosed patients with clinically manifest infantile vitamin B12 deficiency.

Exclusion Criteria

- Patients already diagnosed before the start of the study.
- Unconfirmed suspicion of a manifest infantile vitamin B12 deficiency.
- Age > 12 months of life.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of clinically symptomatic, laboratory-confirmed vitamin B12 deficiency in the first year of life (vitamin B12 in serum/plasma: <160 pmol/l or <215 pg/ml and/or holo-transcobalamin in serum/plasma <35 pmol/l ) in Germany depending on the patient's region of residence/birth, comparing regions with and without newborn screening pilot projects for the identification of neonatal vitamin B12 deficiency.<br>2. Incidence of neonatal vitamin B12 deficiency identified in newborn screening.<br>3. Description of the age profile and clinical spectrum of symptomatic vitamin B12 deficiency at initial manifestation.

Secondary Outcome Measures

Name	Time	Method
1. Description of the anamnestically recorded causes of the vitamin B12 deficiency (resorption disorder of the child, nutrition of the child until diagnosis, maternal nutritional habits, resorption disorders or medication intake).<br>2. Description of the diagnostic work-up (laboratory chemistry, neurological examination, cerebral imaging, EEG examination).