Effect of once weekly folic acid supplementation on erythrocyte folate concentrations in women to determine potential to prevent neural tube defects: A randomised controlled dose-finding trial in Malaysia

Kaitlyn L.I. Samson, Su Peng Loh, Geok Lin Khor, Zalilah Mohd Shariff, Lisa N. Yelland, Shalem Leemaqz, Maria Makrides, Jennifer A. Hutcheon, Dian C. Sulistyoningrum, Jessica J. Yu, Marion L. Roche, Luz Maria De-Regil, Tim J. Green, Crystal D. Karakochuk

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Introduction Folic acid (0.4 mg) taken prior to and during early pregnancy reduces the risk of neural tube defects (NTDs). Because these birth defects occur early in pregnancy, before women may know they are pregnant, many countries have mandated the addition of folic acid to food staples. In countries where fortification is not possible, and weekly iron folic acid programmes exist to reduce anaemia, the WHO recommends that 2.8 mg (7×0.4 mg) folic acid be given instead of the current weekly practice of 0.4 mg. Currently, there is a lack of evidence to support if the 2.8 mg folic acid per week dose is sufficient to raise erythrocyte folate concentrations to a level associated with a reduced risk of a NTD-affected pregnancy. We aim to conduct a three-arm randomised controlled trial to determine the effect of weekly folic acid with iron on erythrocyte folate, a biomarker of NTD risk. Methods and analysis We will recruit non-pregnant women (n=300; 18-45 years) from Selangor, Malaysia. Women will be randomised to receive either 2.8, 0.4 or 0.0 (placebo) mg folic acid with 60 mg iron weekly for 16 weeks, followed by a 4-week washout period. The primary outcome will be erythrocyte folate concentration at 16 weeks and the mean concentration will be compared between randomised treatment groups (intention-to-treat) using a linear regression model adjusting for the baseline measure. Ethics and dissemination Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals. Trial registration numbers ACTRN12619000818134 and NMRR-19-119-45736.

Original languageEnglish
Article numbere034598
Number of pages6
JournalBMJ Open
Volume10
Issue number2
DOIs
Publication statusPublished - 5 Feb 2020
Externally publishedYes

Bibliographical note

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Keywords

  • anaemia
  • folic acid
  • public health
  • women's health

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