研究食用农艺生物强化小麦（Zincol-2016/NR-421）制成的面粉对改善巴基斯坦资源匮乏地区女性锌状况的有效性：一项随机、双盲、对照交叉试验（BiZiFED）的研究方案
Examining the effectiveness of consuming flour made from agronomically biofortified wheat (Zincol-2016/NR-421) for improving Zn status in women in a low-resource setting in Pakistan: study protocol for a randomised, double-blind, controlled cross-over trial (BiZiFED).
作者信息
Lowe Nicola M, Khan Muhammad Jaffar, Broadley Martin R, Zia Munir H, McArdle Harry J, Joy Edward J M, Ohly Heather, Shahzad Babar, Ullah Ubaid, Kabana Gul, Medhi Rashid, Afridi Mukhtiar Zaman
机构信息
International Institute of Nutritional Sciences and Applied Food Safety Studies, Faculty of Health and Wellbeing, University of Central Lancashire, Preston, UK.
Institute of Basic Medical Sciences, Khyber Medical University, Peshawar, Pakistan.
出版信息
BMJ Open. 2018 Apr 17;8(4):e021364. doi: 10.1136/bmjopen-2017-021364.
INTRODUCTION
Dietary zinc (Zn) deficiency is a global problem, particularly in low-income and middle-income countries where access to rich, animal-source foods of Zn is limited due to poverty. In Pakistan, Zn deficiency affects over 40% of the adult female population, resulting in suboptimal immune status and increased likelihood of complications during pregnancy.
METHODS AND ANALYSIS
We are conducting a double-blind, randomised controlled feeding study with cross-over design in a low-resource setting in Pakistan. Households were provided with flour milled from genetically and agronomically biofortified grain (Zincol-2016/NR-421) or control grain (Galaxy-2013). Fifty households were recruited. Each household included a woman aged 16-49 years who is neither pregnant nor breastfeeding, and not currently consuming nutritional supplements. These women were the primary study participants. All households were provided with control flour for an initial 2-week baseline period, followed by an 8-week intervention period where 25 households receive biofortified flour (group A) and 25 households receive control flour (group B). After this 8-week period, groups A and B crossed over, receiving control and biofortified flour respectively for 8 weeks. Tissue (blood, hair and nails) have been collected from the women at five time points: baseline, middle and end of period 1, and middle and end of period 2.
ETHICS AND DISSEMINATION
Ethical approval was granted from the lead university (reference no. STEMH 697 FR) and the collaborating institution in Pakistan. The final study methods (including any modifications) will be published in peer-reviewed journals, alongside the study outcomes on completion of the data analysis. 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.
REGISTRATION DETAILS
The trial has been registered with the ISRCTN registry, study ID ISRCTN83678069.
引言
膳食锌（Zn）缺乏是一个全球性问题，尤其是在低收入和中等收入国家，由于贫困，获取富含锌的动物性食物的机会有限。在巴基斯坦，锌缺乏影响超过40%的成年女性人口，导致免疫状态不佳以及孕期并发症发生的可能性增加。
方法与分析
我们正在巴基斯坦一个资源匮乏地区开展一项采用交叉设计的双盲随机对照喂养研究。为家庭提供由基因和农艺生物强化谷物（Zincol - 2016/NR - 421）磨制的面粉或对照谷物（Galaxy - 2013）。招募了50个家庭。每个家庭包括一名年龄在16至49岁之间、未怀孕且未哺乳、目前未食用营养补充剂的女性。这些女性是主要研究参与者。所有家庭在最初的2周基线期都获得对照面粉，随后是8周的干预期，其中25个家庭接受生物强化面粉（A组），25个家庭接受对照面粉（B组）。在这8周之后，A组和B组交叉，分别接受对照面粉和生物强化面粉8周。已在五个时间点从这些女性身上采集组织（血液、头发和指甲）：基线期、第1期的中期和末期，以及第2期的中期和末期。
伦理与传播
已获得牵头大学（参考编号STEMH 697 FR）和巴基斯坦合作机构的伦理批准。最终的研究方法（包括任何修改）将与数据分析完成后的研究结果一起发表在同行评审期刊上。此外，研究结果将通过会议报告和摘要传播给科学界，并在适当的社区论坛通过村长传达给研究参与者。
注册详情
该试验已在国际标准随机对照试验编号注册中心注册，研究识别号为ISRCTN83678069。
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