Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development

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:
NCT00479479
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.

The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Measure: Outcome is related to changes in Cobalamin status: serum levels of cobalamin and folate, and the metabolic markers, plasma-tHcy, cystathionine and MMA [ Time Frame: Infant age 6 weeks - 4 months ]

Secondary Outcome Measures:
  • Outcome is related to changes in growth parameters; weight, length, head circumference [ Time Frame: Infant age: 6 weeks - 4 months ]

Enrollment: 107
Study Start Date: December 2004
Study Completion Date: December 2006
Detailed Description:

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. A metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants. Whether this profile reflects immature organ systems or cobalamin deficiency has not been clarified.

Low levels of cobalamin, elevated levels of total homocysteine (tHcy), cystathionine and/or methylmalonic acid (MMA) in the blood are measures of impaired cobalamin status.

The purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

Six weeks old infants will be randomly assigned to receive either an intramuscular injection with 400 µg cobalamin or no intervention. Concentrations of cobalamin and folate in serum, and total homocysteine (tHcy), methylmalonic acid (MMA) and cystathionine in plasma will be determined at inclusion and at the age of 4 months. A questionnaire on infant and maternal nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco will be completed.

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 6 weeks old infants
  • The infant should be healthy and not have any serious malformations
  • The mother should be healthy and not have any serious disorders or use any daily medications
  • The mother should have an ordinary omnivorous diet

Exclusion Criteria:

  • If there are evidence of serious infant disease during the study period, the infant should be excluded from the study
  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: NCT00479479

Locations
Norway
Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital
Bergen, Norway, 5018
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. Haukeland University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479479     History of Changes
Other Study ID Numbers: 16941
Study First Received: May 25, 2007
Last Updated: May 25, 2007
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
cobalamin
methylmalonic acid
homocysteine
folate
newborns
infants
Deficiency Disease
Breastfeeding
Infant

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

ClinicalTrials.gov processed this record on July 22, 2014