The effect of folic acid supplementation during pregnancy on the growth, cognitive development and behaviour of 6 and 10 year old children: a follow-up investigation of children of FASSTT study participants

niversity of Ulster (UK)0 个研究点目标入组 119 人开始时间: 2013年5月15日最近更新: 2022年5月30日

适应症

试验速览

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)

•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

•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

发起方

niversity of Ulster (UK)