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 (Responsible Party):

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT00479479

First received: May 25, 2007

Last updated: July 20, 2015

Last verified: July 2015

History of Changes

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:

MedlinePlus related topics: B Vitamins

Drug Information available for: Cyanocobalamin Vitamin B Complex Cobalamin Hydroxocobalamin

U.S. FDA Resources

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
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cobalamin An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)	Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma) an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
No Intervention: No intervention No intervention

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 (Child)
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:

Bjørke Monsen AL, Ueland PM, Vollset SE, Guttormsen AB, Markestad T, Solheim E, Refsum H. Determinants of cobalamin status in newborns. Pediatrics. 2001 Sep;108(3):624-30. Erratum in: Pediatrics 2002 Oct;110(4):853.

Monsen AL, Refsum H, Markestad T, Ueland PM. Cobalamin status and its biochemical markers methylmalonic acid and homocysteine in different age groups from 4 days to 19 years. Clin Chem. 2003 Dec;49(12):2067-75.

Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. Review.

Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bjørke-Monsen AL, Torsvik I, Saetran H, Markestad T, Ueland PM. Common metabolic profile in infants indicating impaired cobalamin status responds to cobalamin supplementation. Pediatrics. 2008 Jul;122(1):83-91. doi: 10.1542/peds.2007-2716.


Responsible Party:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00479479 History of Changes
Other Study ID Numbers:	16941
Study First Received:	May 25, 2007
Last Updated:	July 20, 2015
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 Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamins	Vitamin B 12 Hydroxocobalamin Vitamin B Complex Micronutrients Growth Substances Physiological Effects of Drugs Hematinics

ClinicalTrials.gov processed this record on September 27, 2016

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