To determine whether taking folic acid during the later stages of pregnancy has any beneficial effects of the cognitive development and growth of the offspring

Not Applicable

Completed

• Conditions: Folic acid supplementation in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN19917787
• Lead Sponsor: niversity of Ulster (UK)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29635492 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30777123 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31672132 follow-up results (added 04/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33750355/ (added 23/03/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35578268/ (added 18/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Study Completion: 2019-12-31
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.