Plain English Summary
Background and study aims
Children being exposed to folic acid has become a cause of concern, particularly as it may have adverse events (i.e. damage to health) in the future. There is not yet any published data on the levels of unmetabolised folic acid (UFA) in the circulation of children living in Ireland. The aim of this study is to explore the levels of fasting UFA in the circulation of children living in Ireland exposed to the voluntary folic acid fortification regime in place there.
Who can participate?
Healthy children attending for routine minor surgery at Our Lady’s Hospital, Crumlin, Dublin (Ireland).
What does the study involve?
Participants are asked to provide a fasting 3ml blood sample taken when under a general anaesthetic. The samples are then 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 is also completed face to face with parents.
What are the possible benefits and risks of participating?
This study will help with understanding the intakes of folic acid from fortified foods and supplements in children in Ireland and how this intakes affects their folic acid levels in their blood. Risks are not anticipated.
Where is the study run from?
Our Lady’s Children’s Hospital, Dublin (Ireland)
When is the study starting and how long is it expected to run for?
September 2013 to February 2014
Who is funding the study?
Centre for Preventive Medicine, Dublin City University (Ireland)
Who is the main contact?
Dr Mary Rose Sweeney
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC reference GEN/280/12
Study information
Scientific title
Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification: an observational study
Acronym
Study hypothesis
Aims: To explore the levels of fasting UFA in the circulation of children living in Ireland exposed to the voluntary folic acid fortification regime in place there.
Ethics approval
Research Ethics Committee at Dublin City University and the Ethics Committee at Our Lady’s Children’s Hospital, Crumlin, REC ref: GEN/280/12
Study design
Observational cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Healthy children attending for routine minor surgery
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Unmetabolised folic acid levels, as measured by HPLC.
Secondary outcome measures
Plasma and red cell folate levels, with the analysis conducted in batch assay by L. casei microbiological assay.
Overall trial start date
01/09/2013
Overall trial end date
01/02/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children admitted for routine minor surgery under general anesthetic
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
Unwell children presenting with any condition potentially affecting folate absorption such as a gastrointestinal condition, metabolic condition, shock, burns or post trauma
Recruitment start date
01/09/2013
Recruitment end date
01/02/2014
Locations
Countries of recruitment
Ireland
Trial participating centre
Our Lady’s Children’s Hospital
Crumlin
Dublin
D8
Ireland
Funders
Funder type
University/education
Funder name
Centre for Preventive Medicine, Dublin City University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The paper is being submitted to the American Journal of Clinical Nutrition
Intention to publish date
31/08/2015
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26762371