Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2015
Date assigned
07/10/2015
Last edited
15/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mary Rose Sweeney

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Dublin City University

Sponsor details

Glasnevin
Dublin
D9
Ireland

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26762371

Publication citations

Additional files

Editorial Notes

15/01/2016: Publication reference added.