Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
NCT ID: NCT00479479
Last Updated: 2015-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
107 participants
INTERVENTIONAL
2004-12-31
2006-12-31
Brief Summary
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The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Cobalamin
An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
No intervention
No intervention
No interventions assigned to this group
Interventions
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Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Eligibility Criteria
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Inclusion Criteria
* 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
4 Weeks
4 Months
ALL
Yes
Sponsors
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Norwegian Foundation for Health and Rehabilitation
OTHER
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anne-Lise Bjørke Monsen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
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Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Bjorke 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. doi: 10.1542/peds.108.3.624.
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. doi: 10.1373/clinchem.2003.019869.
Allen LH. Vitamin B12 metabolism and status during pregnancy, lactation and infancy. Adv Exp Med Biol. 1994;352:173-86. doi: 10.1007/978-1-4899-2575-6_14.
Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
Bjorke-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.
Other Identifiers
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16941
Identifier Type: -
Identifier Source: org_study_id
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