Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems

Not Applicable

Completed

• Conditions: Vitamin B 12 Deficiency
• Interventions: Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

• Registration Number: NCT00710359
• Lead Sponsor: Haukeland University Hospital

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 gastrointestinal symptoms and/or feeding problems. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children below 8 months of age
• Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms

Exclusion Criteria

• Children with syndromic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)	400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) given as a single intramuscular injection. The syringe is covered so it is impossible to see whether or not it contains any substance.
2	Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)	The controls receive an intramuscular "injection", however, it is only an introduction of the needle into the muscle, but no injections are given. The syringe is covered so it is impossible to see whether or not it contains any substance.

Primary Outcome Measures

Name	Time	Method
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation	Reevalutation after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Maternal evaluation of changes in infant behaviour and symptoms	After 4 weeks

Trial Locations

Locations (1)

Department of Pediatrics, Haukeland University Hospital; 🇳🇴 Bergen, Norway