Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification.

ISRCTN ISRCTN90038765
DOI https://doi.org/10.1186/ISRCTN90038765
Secondary identifying numbers REC reference GEN/280/12
Submission date
14/07/2015
Registration date
07/10/2015
Last edited
15/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mary Rose Sweeney
Scientific

School of Nursing and Human Sciences
Dublin City University
Glasnevin
Dublin
D9
Ireland

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSynthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification: an observational study
Study objectivesAims: 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(s)Research Ethics Committee at Dublin City University and the Ethics Committee at Our Lady’s Children’s Hospital, Crumlin, REC ref: GEN/280/12
Health condition(s) or problem(s) studiedHealthy children attending for routine minor surgery
InterventionHealthy 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 typeSupplement
Primary outcome measureUnmetabolised folic acid levels, as measured by HPLC.
Secondary outcome measuresPlasma and red cell folate levels, with the analysis conducted in batch assay by L. casei microbiological assay.
Overall study start date01/09/2013
Completion date01/02/2014

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants60
Key inclusion criteriaChildren admitted for routine minor surgery under general anesthetic
Key exclusion criteriaUnwell children presenting with any condition potentially affecting folate absorption such as a gastrointestinal condition, metabolic condition, shock, burns or post trauma
Date of first enrolment01/09/2013
Date of final enrolment01/02/2014

Locations

Countries of recruitment

  • Ireland

Study participating centre

Our Lady’s Children’s Hospital
Crumlin
Dublin
D8
Ireland

Sponsor information

Dublin City University
University/education

Glasnevin
Dublin
D9
Ireland

ROR logo "ROR" https://ror.org/04a1a1e81

Funders

Funder type

University/education

Centre for Preventive Medicine, Dublin City University

No information available

Results and Publications

Intention to publish date31/08/2015
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe paper is being submitted to the American Journal of Clinical Nutrition
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2016 Yes No

Editorial Notes

15/01/2016: Publication reference added.