Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification.
| ISRCTN | ISRCTN90038765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90038765 |
| Protocol serial number | REC reference GEN/280/12 |
| Sponsor | Dublin City University |
| Funder | Centre for Preventive Medicine, Dublin City University |
- 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
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
Scientific
School of Nursing and Human Sciences
Dublin City University
Glasnevin
Dublin
D9
Ireland
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification: an observational study |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Unmetabolised folic acid levels, as measured by HPLC. |
| Key secondary outcome measure(s) |
Plasma and red cell folate levels, with the analysis conducted in batch assay by L. casei microbiological assay. |
| Completion date | 01/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Children admitted for routine minor surgery under general anesthetic |
| Key exclusion criteria | Unwell children presenting with any condition potentially affecting folate absorption such as a gastrointestinal condition, metabolic condition, shock, burns or post trauma |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 01/02/2014 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D8
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/01/2016: Publication reference added.
