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Completed

NCT Number: NCT00710138

Cobalamin Status in Young Children With Developmental Delay

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.

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Key information

Conditions

Vitamin B 12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin B Deficiency

Age range

Up to 8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatrics, Haukeland University Hospital

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

Dietary Supplement

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

Other names: Vitamin B12, Cobalamin, B vitamins

Primary outcomes

  1. Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters

    Time frame: Reevalutation after 4 weeks

Secondary outcomes

  1. Maternal evaluation of infant behaviour

    Time frame: After 4 weeks

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

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

Registry information

Official study title

Cobalamin Status in Young Children With Developmental Delay and Regression

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2008
Registry last updated
Aug 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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