Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
Primary Purpose
Vitamin B 12 Deficiency
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
Sponsored by
About this trial
This is an interventional basic science trial for Vitamin B 12 Deficiency focused on measuring cobalamin, methylmalonic acid, homocysteine, folate, newborns, infants, Deficiency Disease, Breastfeeding, Infant
Eligibility 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
Sites / Locations
- Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cobalamin
No intervention
Arm Description
An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
No intervention
Outcomes
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
Secondary Outcome Measures
Outcome is related to changes in growth parameters; weight, length, head circumference
Full Information
NCT ID
NCT00479479
First Posted
May 25, 2007
Last Updated
July 20, 2015
Sponsor
Haukeland University Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation, Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
1. Study Identification
Unique Protocol Identification Number
NCT00479479
Brief Title
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
Official Title
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation, Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B 12 Deficiency
Keywords
cobalamin, methylmalonic acid, homocysteine, folate, newborns, infants, Deficiency Disease, Breastfeeding, Infant
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cobalamin
Arm Type
Experimental
Arm Description
An intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
Intervention Description
an intramuscular injection of 400 µg hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma, Norway)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Outcome is related to changes in growth parameters; weight, length, head circumference
Time Frame
Infant age: 6 weeks - 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Bjørke Monsen, M.D., Ph.D.
Organizational Affiliation
Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Clinical Biochemistry and Department of Pediatrics; Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5018
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
11533328
Citation
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. Erratum In: Pediatrics 2002 Oct;110(4):853.
Results Reference
background
PubMed Identifier
14633879
Citation
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.
Results Reference
background
PubMed Identifier
7832046
Citation
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.
Results Reference
background
PubMed Identifier
9930566
Citation
Rosenblatt DS, Whitehead VM. Cobalamin and folate deficiency: acquired and hereditary disorders in children. Semin Hematol. 1999 Jan;36(1):19-34.
Results Reference
background
PubMed Identifier
18595990
Citation
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.
Results Reference
derived
Learn more about this trial
Cobalamin Supplementation During Infancy; Effect on B-vitamin Status, Growth and Psychomotor Development
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