The Folate Study
Research type
Research Study
Full title
Evaluating the Impact of Folic Acid Fortification of Non-Wholemeal Wheat Flour on Maternal-Fetal and Child Outcomes among UK multi-ethnic populations (The Folate Study).
IRAS ID
358681
Contact name
Rebecca M Reynolds
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Folate is a B-vitamin essential for the development of the developing baby’s brain and spine during early pregnancy. In the UK, about 90% of women of childbearing age have low folate levels.
Low folate levels in pregnancy increase the risk of neural tube defects (NTDs), including spina bifida (when the spine and spinal cord do not form properly). Most of these pregnancies result in miscarriage, stillbirth, termination, or significant disability. Low levels of folate have also been linked to pregnancy complications such as maternal anaemia, and babies being born too small or too early.
To reduce this risk, NHS guidelines recommend that a daily folic supplement is taken while planning for a pregnancy until 12 weeks of pregnancy. This supports neural tube development in the early weeks of pregnancy.
However, nearly half of pregnancies are unplanned and many people don’t take folic acid supplements. This means that many pregnancies are still at a higher risk of NTDs and pregnancy complications. To address this, the UK Government will introduce folic acid fortification of white flour (adding folic acid to the flour) which is expected to prevent about 20% of NTDs.
Many countries already add folic acid to their foods, which has helped lower the rates of NTDs. However, the levels of fortification and types of fortified foods differ between countries. This study (along with other institutions as part of a larger study on their own approvals/ethics) will collect: blood samples before, during and after fortification; information on diet and folic acid intake; and data on maternal and baby health outcomes, from families in NHS Lothian to find out whether folate fortification in the UK will lower rates of NTDs.
REC name
HSC REC B
REC reference
25/NI/0167
Date of REC Opinion
23 Dec 2025
REC opinion
Further Information Favourable Opinion