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).
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).
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DOI：
10.1136/bmjopen-2017-021364
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发表时间：
2018-04-17
期刊：
影响因子：
2.9
通讯作者：
Afridi MZ
中科院分区：
文献类型：
--
作者：
Lowe NM;Khan MJ;Broadley MR;Zia MH;McArdle HJ;Joy EJM;Ohly H;Shahzad B;Ullah U;Kabana G;Medhi R;Afridi MZ
膳食锌缺乏症是一个全球性问题，特别是在低收入和中等收入国家，由于贫困，这些国家获得富含锌的动物源食品的机会有限。在巴基斯坦，锌缺乏症影响到40%以上的成年女性人口，导致免疫状态不佳，并增加了怀孕期间并发症的可能性。我们正在巴基斯坦一个资源匮乏的环境中进行一项交叉设计的双盲、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（zincoll -2016/NR-421）或对照谷物（Galaxy-2013）碾磨而成的面粉。招募了50户家庭。每个家庭都有一名16-49岁的妇女，既没有怀孕，也没有哺乳，目前也没有服用营养补充剂。这些女性是研究的主要参与者。在最初的2周基线期，所有家庭都获得了对照面粉，随后是8周的干预期，其中25个家庭获得了生物强化面粉（A组），25个家庭获得了对照面粉（B组）。8周后，A组和B组进行交叉，分别饲喂对照粉和生物强化粉8周。组织（血液、头发和指甲）在五个时间点采集：基线、第一期中期和结束、第二期中期和结束。伦理批准获得了领先大学(参考编号STEMH 697 FR)和巴基斯坦的合作机构。最终的研究方法（包括任何修改）将与完成数据分析的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发言和摘要传播给科学界，并在适当的社区论坛上通过村庄长老传达给研究参与者。该试验已在ISRCTN注册中心注册，研究ID为ISRCTN83678069。
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. 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. 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. The trial has been registered with the ISRCTN registry, study ID ISRCTN83678069.
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