Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 10:34 AM
Study NCT ID:
NCT00710359
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Sponsor:
Haukeland University Hospital
Organization:
Study Overview
Official Title:
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: