A double blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron.
A double blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron.
复制标题
一项双盲随机对照试验，比较了孕妇补铁的标准剂量与两种筛查和治疗方法，使用铁调素作为准备和安全接受铁的生物标志物。
DOI：
10.1186/s12884-016-0934-8
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发表时间：
2016-07-13
影响因子：
3.1
通讯作者：
Prentice AM
中科院分区：
文献类型：
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作者：
Bah A;Wegmuller R;Cerami C;Kendall L;Pasricha SR;Moore SE;Prentice AM
直到最近，世卫组织还建议贫血率超过40%的所有孕妇每天补充铁（60毫克/天铁与400微克/天叶酸结合）。最近的研究表明，这可能对孕妇构成风险。因此，有必要探索筛查和治疗方案，以尽量减少怀孕期间的铁暴露，使用总体较低剂量的铁，达到与世卫组织目前推荐的效果相当的效果。然而，对于感染普遍存在时如何最好地评估铁缺乏症，目前尚无一致意见。在这里，我们测试使用hepcidin肽激素和铁代谢的关键调节剂，作为“安全和准备接受”铁的潜在指标。这是一项3组随机对照概念验证试验。我们将测试以下假设：使用预先确定的铁调素截止值<2.5 ng/ml的筛查和治疗方法来补充铁，将在较低的铁剂量下在预防缺铁和贫血方面实现相似的功效，因此将提高安全性。将在冈比亚农村地区随机抽取462名孕妇，接受：a）联合国大学/儿童基金会/卫生组织国际多种微量营养素制剂（UNIMMAP），含铁60毫克/天（参照组）; B）含有60 mg/d铁但基于每周铁调素筛选的UNIMMAP，所述筛选指示在接下来的7天内是否可以给予铁; c）或如（B）中的含30 mg/d铁的UNIMMAP，在冈比亚农村持续12周。本研究将使用血红蛋白水平的主要终点（非劣效性界值为0.5 g/dl）检验筛选和治疗方法是否非劣效于参考组。还将评估副作用、依从性和补铁对感染易感性的影响等次要结局。这项试验预计将有助于尽量减少孕妇接触可能不需要的铁，因此可能有害。如果本研究中的证据表明，整体较低剂量的铁不劣于60 mg/天的铁，这可能有助于减少副作用，提高依从性和增加安全性。使用铁调素进行简单的护理点诊断的潜力，当它是最安全和有效的铁可以改善孕产妇健康结果。ISRCTN21955180
Until recently, WHO recommended daily iron supplementation for all pregnant women (60 mg/d iron combined with 400ug/d folic acid) where anaemia rates exceeded 40 %. Recent studies indicate that this may pose a risk to pregnant women. Therefore, there is a need to explore screen-and-treat options to minimise iron exposure during pregnancy using an overall lower dosage of iron that would achieve equivalent results as being currently recommended by the WHO. However, there is a lack of agreement on how to best assess iron deficiency when infections are prevalent. Here, we test the use of hepcidin a peptide hormone and key regulator of iron metabolism, as a potential index for ‘safe and ready to receive’ iron. This is a 3-arm randomised-controlled proof-of-concept trial. We will test the hypothesis that a screen-and-treat approach to iron supplementation using a pre-determined hepcidin cut-off value of <2.5 ng/ml will achieve similar efficacy in preventing iron deficiency and anaemia at a lower iron dose and hence will improve safety. A sample of 462 pregnant women in rural Gambia will be randomly assigned to receive: a) UNU/UNICEF/WHO international multiple micronutrient preparation (UNIMMAP) containing 60 mg/d iron (reference arm); b) UNIMMAP containing 60 mg/d iron but based on a weekly hepcidin screening indicating if iron can be given for the next 7 days or not; c) or UNIMMAP containing 30 mg/d iron as in (b) for 12 weeks in rural Gambia. The study will test if the screen-and-treat approach is non-inferior to the reference arm using the primary endpoint of haemoglobin levels at a non-inferiority margin of 0.5 g/dl. Secondary outcomes of adverse effects, compliance and the impact of iron supplementation on susceptibility to infections will also be assessed. This trial is expected to contribute towards minimising the exposure of pregnant women to iron that may not be needed and therefore potentially harmful. If the evidence in this study shows that the overall lower dosage of iron is non-inferior to 60 mg/day iron, this may help decrease side-effects, improve compliance and increase safety. The potential for the use of hepcidin for a simple point-of-care (PoC) diagnostic for when it is most safe and effective to give iron may improve maternal health outcomes. ISRCTN21955180