FACT 4 Child
Research type
Research Study
Full title
Folic Acid Clinical Trial: Follow up of children (FACT 4 Child)
IRAS ID
276185
Contact name
Janet Berrington
Contact email
Sponsor organisation
Ottawa Hospital Research Institute
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 4 months, 25 days
Research summary
The potential effect of folic acid supplementation during pregnancy on child neurocognitive development and developmental disorders is not known. Using population recruited into the previous FACT study, mums randomised to folic acid supplementation or placebo. We have an opportunity to prospectively examine potential associations between high dose folic acid and developmental outcomes in children. The FACT 4 Child will make use of the treatment allocation of the original FACT RCT to determine potential associations with outcomes 4-6 years following delivery. FACT 4 Child will provide important evidence of the effect of maternal folic acid supplementation on neurocognitive and behavioural problems associated with ASD and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death in young children and give evidence in support of the management of folic acid dosing during pregnancy
REC name
London - Brent Research Ethics Committee
REC reference
21/PR/0292
Date of REC Opinion
19 Apr 2021
REC opinion
Further Information Favourable Opinion