Biofortification of wheat with zinc for eliminating deficiency in Pakistan: study protocol for a cluster-randomised, double-blind, controlled effectiveness study (BIZIFED2).
Biofortification of wheat with zinc for eliminating deficiency in Pakistan: study protocol for a cluster-randomised, double-blind, controlled effectiveness study (BIZIFED2).
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DOI：
10.1136/bmjopen-2020-039231
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发表时间：
2020-11-18
期刊：
影响因子：
2.9
通讯作者：
Khan MJ
中科院分区：
文献类型：
--
作者：
Lowe NM;Zaman M;Moran VH;Ohly H;Sinclair J;Fatima S;Broadley MR;Joy EJM;Mahboob U;Lark RM;Zia MH;Ander EL;Sharp PA;Bailey EH;Young SD;Khan MJ
微量营养素缺乏症通常被称为“隐性饥饿”，影响着全世界超过 20 亿人，其中锌和铁缺乏症的报道屡见不鲜。本研究的目的是探讨食用锌生物强化面粉 (Zincol-2016) 对生活在巴基斯坦资源匮乏环境中的少女和儿童的生化和功能状况测量的影响。我们正在进行一项务实、整群随机、双盲、对照试验。距白沙瓦约 30-40 公里的两个集水区总共招募了 482 户家庭。家庭纳入标准是同时存在一名 10-16 岁的少女和一名 1-5 岁的儿童。研究期限为12个月，分为两个为期6个月的阶段。在第一阶段，将为所有家庭提供当地采购的标准小麦品种面粉。在第二阶段，集群将被配对，并随机分配到研究的对照组或干预组。干预组将提供锌生物强化小麦粉，目标锌浓度为 40 毫克/千克。控制臂将使用当地采购的标准品种小麦粉，预期锌浓度为 20 毫克/千克。主要结果指标是血浆锌浓度。次要结果包括人体测量、铁和锌状态的生物标志物以及呼吸道感染和腹泻的存在和持续时间。中央兰开夏大学 STEMH 伦理委员会（参考号：STEMH 1014）和开伯尔医科大学伦理委员会（DIR/KMU-EB/BZ/000683）授予伦理批准。最终的研究方法将与研究结果一起发表在同行评审的期刊上。此外，研究结果将通过会议演讲和摘要向科学界传播，并通过村庄长者在适当的社区论坛上传达给研究参与者。 ISRCTN17107812；预结果。
Micronutrient deficiencies, commonly referred to as ‘hidden hunger’, affect more than two billion people worldwide, with zinc and iron-deficiency frequently reported. The aim of this study is to examine the impact of consuming zinc biofortified flour (Zincol-2016) on biochemical and functional measures of status in adolescent girls and children living in a low-resource setting in Pakistan. We are conducting a pragmatic, cluster-randomised, double-blind, controlled trial. A total of 482 households have been recruited from two catchment areas approximately 30–40 km distance from Peshawar. Household inclusion criteria are the presence of both an adolescent girl, aged 10–16 years, and a child aged 1–5 years. The study duration is 12 months, divided into two 6-month phases. During phase 1, all households will be provided with locally procured flour from standard varieties of wheat. During phase 2, clusters will be paired, and randomised to either the control or intervention arm of the study. The intervention arm will be provided with zinc biofortified wheat flour, with a target zinc concentration of 40 mg/kg. The control arm will be provided with locally procured wheat flour from standard varieties with an expected zinc concentration of 20 mg/kg. The primary outcome measure is plasma zinc concentration. Secondary outcomes include anthropometric measurements, biomarkers of iron and zinc status, and the presence and duration of respiratory tract infections and diarrhoea. Ethical approval was granted from the University of Central Lancashire STEMH Ethics Committee (reference number: STEMH 1014) and Khyber Medical University Ethics Committee (DIR/KMU-EB/BZ/000683). The final study methods will be published in peer-reviewed journals, alongside the study outcomes. In addition, findings will be disseminated to the scientific community via conference presentations and abstracts and communicated to the study participants through the village elders at an appropriate community forum. ISRCTN17107812; Pre-results.
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