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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN90038765 |
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Date of registration:
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07/10/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification.
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Scientific title:
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Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification: an observational study |
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Date of first enrolment:
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01/09/2013 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN90038765 |
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Study type:
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Observational |
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Study design:
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Observational cross-sectional study (Other)
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Phase:
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mary Rose
Sweeney |
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Address:
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School of Nursing and Human Sciences
Dublin City University
Glasnevin
D9
Dublin
Ireland |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Children admitted for routine minor surgery under general anesthetic
Exclusion criteria: Unwell children presenting with any condition potentially affecting folate absorption such as a gastrointestinal condition, metabolic condition, shock, burns or post trauma
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy children attending for routine minor surgery
Nutritional, Metabolic, Endocrine
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Intervention(s)
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Healthy children attending for routine minor surgery at Our Lady’s Hospital, Crumlin, Dublin were recruited to provide a fasting 3ml blood sample taken while administering a general anaesthetic. The samples were analysed for plasma and red cell folate and UFA levels. A short dietary questionnaire capturing recent and habitual intake of folic acid both as supplements, and as fortified foods was completed face to face with parents.
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Primary Outcome(s)
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Unmetabolised folic acid levels, as measured by HPLC.
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Secondary Outcome(s)
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Plasma and red cell folate levels, with the analysis conducted in batch assay by L. casei microbiological assay.
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Secondary ID(s)
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REC reference GEN/280/12
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Source(s) of Monetary Support
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Centre for Preventive Medicine, Dublin City University
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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