Cobalamin Status in Young Children With Developmental Delay

This study has been completed.
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00710138
First received: July 2, 2008
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Vitamin B 12 Deficiency
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cobalamin Status in Young Children With Developmental Delay and Regression

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, neurological evaluation and growth parameters [ Time Frame: Reevalutation after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal evaluation of infant behaviour [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Other Names:
  • Vitamin B12
  • Cobalamin
  • B vitamins
Sham Comparator: 2
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.
Dietary Supplement: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma), as a single intramuscular injection
Other Names:
  • Vitamin B12
  • Cobalamin
  • B vitamins

  Eligibility

Ages Eligible for Study:   up to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710138

Locations
Norway
Department of Pediatrics, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Norwegian Foundation for Health and Rehabilitation
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Investigators
Principal Investigator: Anne-Lise Bjørke Monsen, M.D., Ph.D. Laboratory of Clinical Biochemistry, Haukeland University Hospital, N-5021 Bergen, Norway
Study Director: Per Magne Ueland, M.D., Ph.D. Department of Internal Medicine, University of Bergen, 5021 Armauer Hanssen Hus, Bergen, NORWAY
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne-Lise Bjørke Monsen, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00710138     History of Changes
Other Study ID Numbers: 19072
Study First Received: July 2, 2008
Last Updated: August 13, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Norwegian Institute of Public Health

Keywords provided by Haukeland University Hospital:
Cobalamin deficiency
Infant
Nutrition
Cobalamin supplementation
Neurodevelopment
Neurological symptoms

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014