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Cobalamin Status in Young Children With Developmental Delay

Cobalamin Status in Young Children With Developmental Delay and Regression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00710138
Enrollment
100
Registered
2008-07-04
Start date
2008-06-30
Completion date
2010-08-31
Last updated
2010-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin B 12 Deficiency

Keywords

Cobalamin deficiency, Infant, Nutrition, Cobalamin supplementation, Neurodevelopment, Neurological symptoms

Brief summary

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition. In this study we want to establish the prevalence of cobalamin deficiency in infants with developmental delay and regression and other vague neurological symptoms. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status. Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.

Interventions

400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection

Sponsors

Norwegian Foundation for Health and Rehabilitation
CollaboratorOTHER
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
CollaboratorOTHER
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Months
Healthy volunteers
No

Inclusion criteria

* Children below 8 months of age * Clinical diagnosis or symptoms: developmental delay and regression and other vague neurological symptoms

Exclusion criteria

* Children with syndromic disease

Design outcomes

Primary

MeasureTime frame
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parametersReevalutation after 4 weeks

Secondary

MeasureTime frame
Maternal evaluation of infant behaviourAfter 4 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026