Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA
Food Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
BMJ Open. 2024 Oct 29;14(10):e084494. doi: 10.1136/bmjopen-2024-084494.
The prevalence of neural tube defects (NTDs) is higher in Ethiopia than most other countries, and ~84% of Ethiopian women of reproductive age (WRA) have folate insufficiency, a major risk factor for NTDs. Salt fortification with folic acid is a potential strategy to improve women's folate status, but data are needed on the acceptability, nutritional impact and safety of folic acid fortification of iodised salt.
The study is designed as a community-based, household-randomised, dose-response trial. A total of 360 non-pregnant WRA 18-49 years of age will be randomly assigned to one of three intervention arms: (1) iodised salt fortified with 30 ppm folic acid to provide ~200 µg folic acid/day; (2) iodised salt fortified with 90 ppm folic acid to provide ~600 µg folic acid/day; or (3) iodised salt (comparator). The preweighed salts will be delivered to participants' homes biweekly for 26 weeks; unused salt will be collected and weighed. Fasting, venous blood samples will be collected at baseline, end line and a randomly assigned intermediate time point for assessment of folate, iodine, vitamin B and other micronutrient status biomarkers. Women's dietary intakes, including discretionary salt consumption, will be measured using weighed food records; 24-hour urine specimens will be analysed for sodium and iodine excretion. Primary outcomes are women's consumption of study salts, change in biomarkers of folate and iodine status and prevalence of adverse events. Results will be analysed using analysis of covariance models to estimate group mean differences for continuous outcomes, controlling for baseline measurements, and log-binomial or modified Poisson regressions for categorical outcomes. Prespecified effect modifications will be explored.
The study has been approved by the Ethiopian Public Health Institute's Institutional Review Board, and the protocol has been registered with ClinicalTrials.gov (registration number NCT06223854). Study results will be published in open access scientific journals and disseminated nationally in Ethiopia.
NCT06223854.
神经管缺陷（NTDs）在埃塞俄比亚的流行率高于大多数其他国家，约 84%的育龄妇女（WRA）存在叶酸不足，这是 NTDs 的主要危险因素。叶酸盐强化盐是改善妇女叶酸状况的一种潜在策略，但需要了解叶酸盐强化碘盐的可接受性、营养影响和安全性。
该研究设计为基于社区的、家庭随机、剂量反应试验。总共将随机分配 360 名 18-49 岁的非孕妇 WRA 进入以下三个干预组之一：（1）添加 30ppm 叶酸的碘盐，以提供约 200μg 叶酸/天；（2）添加 90ppm 叶酸的碘盐，以提供约 600μg 叶酸/天；或（3）碘盐（对照）。将预称重的盐每两周分发给参与者的家中，持续 26 周；未使用的盐将被收集并称重。在基线、终点和随机指定的中间时间点采集空腹静脉血样，以评估叶酸、碘、维生素 B 和其他微量营养素状态生物标志物。使用称重食物记录测量妇女的饮食摄入量，包括随意摄入的盐量；分析 24 小时尿液样本中的钠和碘排泄量。主要结局是妇女对研究盐的消耗、叶酸和碘状态生物标志物的变化以及不良事件的发生率。使用协方差模型分析结果，以估计连续结局的组均值差异，控制基线测量值，并对数二项式或修正泊松回归分析分类结局。将探索预设的效果修饰。
该研究已获得埃塞俄比亚公共卫生研究所机构审查委员会的批准，方案已在 ClinicalTrials.gov 注册（注册号 NCT06223854）。研究结果将在开放获取的科学期刊上发表，并在埃塞俄比亚全国范围内传播。
NCT06223854。
