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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00479479 |
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Date of registration:
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25/05/2007 |
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Primary sponsor: |
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Public title:
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Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development
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Scientific title:
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Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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107 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00479479 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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Norway
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Contacts
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Name:
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Anne-Lise Bjørke Monsen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Haukeland University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
4 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vitamin B 12 Deficiency
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Intervention(s)
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Drug: Hydroxycobalamin (Vitamin B12 Depot, Nycomed Pharma)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Outcome is related to changes in growth parameters; weight, length, head circumference
[Time Frame: Infant age: 6 weeks - 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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