Siddiqua Towfida Jahan, Schulze Kerry J, Hasan Sm Tafsir, Ahsan Khalid Bin, Bandyopadhyay Sulagna, Zavala Eleonor, Ali Hasmot, Haque Rezwanul, Sujan Hasan Mahmud, Rahman Md Hafizur, Baker Sarah, Stephenson Katherine K, Ge Ximing, Gough Ethan K, Langevin Brooke, Wu Lee Shu Fune, Dyer Brian, Roy Anjan Kumar, Jubair Mohammad, Nishan Amena Al, Rosenblum Michael, Gopalakrishnan Mathangi, Kraemer Klaus, Erchick Daniel J, Ahmed Tahmeed, Christian Parul
JiVitA Project, Rangpur, Bangladesh.
Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
BMJ Open. 2025 Jan 4;15(1):e090108. doi: 10.1136/bmjopen-2024-090108.
Optimising the micronutrient status of women before and during reproduction confers benefits to them and their offspring. Antenatal multiple micronutrient supplements (MMS), given as a daily tablet with nutrients at ~1 recommended dietary allowance (RDA) or adequate intake (AI) reduces adverse birth outcomes. However, at this dosage, MMS may not fully address micronutrient deficiencies in settings with chronically inadequate diets and infection. A bioefficacy study to determine amounts required to attain nutrient adequacy among women of reproductive age (WRA) and pregnant women (PW) aims to address this gap.
Two, four-arm, dose-response trials (n=240 participants/trial) with a double-blind, individually randomised, controlled design are underway in 18-35 year-old WRA and PW in rural northern Bangladesh. The trials will test dose response to four levels of 19 micronutrients from 1 RDA/AI up to 75% of the tolerable upper intake level (UL), where applicable. These levels of micronutrients are delivered in the form of a reconstituted (in water) powdered drink, daily, including a placebo drink in the control arm, plus a fortified, balanced energy and protein (BEP) food product containing each micronutrient at ~1 RDA per serving. The supplement duration is 3 months in WRA and6 months (until birth) in PW, who are enrolled at 12-16 weeks of pregnancy; women are randomised to one of the four arms at enrolment. Supplement consumption is directly observed by study staff and weekly side effects and adverse events are monitored. Blood and urine are collected at baseline, a midpoint, and at/near the end of supplementation, with a birth visit and postpartum biospecimen collection (post supplementation) for PW. Outcomes are biomarkers of nutrient status. Pharmacokinetic modelling will estimate micronutrient intakes at which sufficiency for each nutrient without excess is achieved. Enrolment was initiated on 22 October 2023.
The study was approved by the Institutional Review Board of Johns Hopkins Bloomberg School of Public Health and the research and ethical review committees of icddr,b, Bangladesh. A data safety and monitoring board is in place for the study. Findings will be disseminated in peer-reviewed papers and in-country meetings.
NCT06081114Cite Now.
优化女性在孕前和孕期的微量营养素状况对她们自身及其后代有益。产前多种微量营养素补充剂（MMS），以每日一片含有约1推荐膳食摄入量（RDA）或适宜摄入量（AI）营养素的片剂形式服用，可减少不良分娩结局。然而，在此剂量下，在饮食长期不足和存在感染的环境中，MMS可能无法完全解决微量营养素缺乏问题。一项生物有效性研究旨在确定育龄妇女（WRA）和孕妇（PW）达到营养素充足所需的量，以填补这一空白。
在孟加拉国北部农村地区18至35岁的育龄妇女和孕妇中正在进行两项四臂剂量反应试验（每项试验n = 240名参与者），采用双盲、个体随机对照设计。试验将测试对19种微量营养素从1 RDA/AI到适用情况下可耐受最高摄入量（UL）约75%的四个水平的剂量反应。这些微量营养素水平以一种复溶（于水中）的粉状饮料形式每日提供，包括对照组的安慰剂饮料，外加一种强化的、能量和蛋白质均衡（BEP）的食品，每份含有每种微量营养素约1 RDA。补充剂持续时间在育龄妇女中为3个月，在孕妇中约为6个月（直至分娩），孕妇在怀孕12至16周时入组；妇女在入组时随机分配到四个组之一。研究人员直接观察补充剂的服用情况，并每周监测副作用和不良事件。在基线、中点以及补充剂结束时/接近结束时采集血液和尿液，对孕妇进行分娩访视并在产后（补充剂后）采集生物样本。结局指标为营养状况的生物标志物。药代动力学模型将估计每种营养素达到充足且无过量时的微量营养素摄入量。入组于2023年10月22日开始。
该研究经约翰霍普金斯大学布隆伯格公共卫生学院机构审查委员会以及孟加拉国icddr,b的研究和伦理审查委员会批准。该研究设有数据安全和监测委员会。研究结果将在同行评审论文和国内会议上发表。
NCT06081114立即引用。
