Folic acid supplementation in pregnancy Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 10/10/2017:
In 2005/2007 a randomised controlled trial investigating the effect of Folic Acid Supplementation during the Second and Third Trimester (FASSTT)
the results were compared for the two intervention groups.
For the purpose of the follow-up investigation, children who were born to mothers who took part in the FASSTT trial will be a
Sponsors
University of Ulster (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/07/2017: 1. The FASSTT trial involved healthy women in the first trimester of pregnancy with singleton pregnancies, without current pregnancy complications, and aged between 18 and 35y. 2. Women who participated in a previous randomized controlled trial (FASSTT study, REC ref: 05/Q2008/21) and their healthy children aged 6-7y and 10-11y who were born as singleton live births to mothers who completed the trial in the 2nd and 3rd trimesters of pregnancy. 3. Parents who consented and children who assented to their participation in follow-up studies in which cognitive development and growth were measured. Previous inclusion criteria: Woman who participanted in a previous randomised controlled trial (FASSTT study, REC reference: 05/Q2008/21) and their children
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 27/07/2017: 1. The FASSTT trial excluded women from participation if during the first trimester of pregnancy they had taken folic acid supplements at a dose above 400µg/d, if they had gastrointestinal, hepatic, renal, or vascular disease, hematologic disorders, epilepsy, a previous pregnancy with an NTD or were the first degree relative of a woman who had a pregnancy with an NTD, or were themselves a sufferer of an NTD. Participants who were taking a medication known to interfere with B vitamin metabolism or those who had undergone in vitro fertilization treatment were also excluded. 2. Any child who has a severe current health problem or disability with impact on cognitive development (primary outcome measure) 3. Any child whose informed written consent cannot be obtained from the parent/guardian 4. Any child who refuses to have the measurements taken Previous exclusion criteria: 1. Any child who has a severe current health problem or disability with impact on cognitive development (primary outcome measure) 2. Any child whose informed written consent cannot be obtained from the parent/guardian 3. Any child who refuses to have the measurements taken
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of folic acid supplementation during pregnancy on cognitive development of the offspring aged 6 and 10 years. Each child will undergo a cognitive assessment at approximately 6 years of age using the Wechsler Preschool and Primary Scale of Intelligence test, 3rd edition (WPPSI) and at the age of 10 years using the Wechsler Intelligence Scale for Children, 4th UK edition (WISC-IV). The cognitive assessments are composed of a battery of subtests, sampling a broad spectrum of behaviour. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of folic acid supplementation during pregnancy on the offspring’s growth, behaviour, brain activity and DNA methylation. Anthropometric measurements of the child will be taken by using standard equipment; weight (digital weighing scales), height (stadiometer), waist circumference (non-stretchable tape) and body fat (portable bioelectrical impedance scales). In addition, a buccal swab and blood sample (age 10 years only) of each child will be taken for DNA methylation and B-vitamin analysis. In a random selection of FASSTT children age 10 years old, brain activity assessments will be carried out by magnetoencephalography (MEG). The MEG machine will be used to assess brain function by passively measuring the magnetic fields produced by neurons in the brain. The current study will be the first of its kind to report the use of MEG neuro-imaging in a nutritional investigation of children. Ulster University, Magee has one of the few MEG machines in the UK (and the only one on the Island of Ireland) and the expertise to apply this safe and unintimidating procedure in children. | — |
Countries
Northern Ireland, United Kingdom
Outcome results
None listed