Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.
Healthy Starts, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.
BMJ Open. 2020 Feb 5;10(2):e034598. doi: 10.1136/bmjopen-2019-034598.
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.
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.
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.
ACTRN12619000818134 and NMRR-19-119-45736.
在怀孕前和怀孕早期服用叶酸（0.4 毫克）可降低神经管缺陷（NTD）的风险。由于这些出生缺陷发生在怀孕早期，女性可能还不知道自己已经怀孕，因此许多国家都强制在主食中添加叶酸。在无法进行强化的国家，以及为了减少贫血而存在每周补铁叶酸方案的国家，世卫组织建议，应给予 2.8 毫克（7×0.4 毫克）叶酸，而不是目前每周 0.4 毫克的做法。目前，缺乏证据表明每周 2.8 毫克叶酸剂量是否足以将红细胞叶酸浓度提高到与降低 NTD 相关的风险水平。我们旨在开展一项三臂随机对照试验，以确定每周补铁叶酸对红细胞叶酸的影响，红细胞叶酸是 NTD 风险的生物标志物。
我们将从马来西亚雪兰莪招募 300 名非孕妇（18-45 岁）。女性将被随机分为三组，分别接受每周 2.8、0.4 或 0.0（安慰剂）毫克叶酸与 60 毫克铁，持续 16 周，随后进行 4 周洗脱期。主要结局是 16 周时的红细胞叶酸浓度，使用线性回归模型比较随机治疗组之间的平均浓度（意向治疗），并调整基线测量值。
该研究已获得不列颠哥伦比亚大学（H18-00768）和马来西亚博特拉大学（JKEUPM-2018-255）的伦理批准。本试验结果将在科学会议上报告，并在同行评议期刊上发表。
ACTRN12619000818134 和 NMRR-19-119-45736。
