Integrating seasonal malaria chemoprevention (SMC), recommended by the WHO since 2012 to prevent malaria infection, with nutrition interventions may improve health outcomes and operational efficiencies. This study assessed the effects of co-packaging interventions on distribution coverage, nutrition, and clinical malaria outcomes in northern Nigeria. From August to November 2014, community volunteers delivered sulfadoxine-pyrimethamine and amodiaquine (SP-AQ) door-to-door each month to approximately 7,000 children aged 6-24 months in seven wards of Madobi, Kano State, Nigeria. In three of the wards children additionally received a lipid-based nutrient supplement (LNS-medium quantity), Plumpy Doz. Coverage, adherence, and anthropometric outcomes were assessed through baseline, midline, and endline household surveys. A facility-based case-control study was also conducted to estimate impact on clinical malaria outcomes. Coverage of SP-AQ was similar between arms at 89% (n = 2,409 child-months [88-90%]) in the SP-AQ only arm and 90% (n = 1,947 child-months [88-92%]) in the SP-AQ plus LNS arm (p = 0.52). Coverage of LNS was 83% (n = 2,409 child-months [81-84%]). Whilst there were marked changes in anthropometric status between baseline, midline and endline, these were largely accounted for by socioeconomic status and must be interpreted with care due to possible measurement issues, especially length-based indices. Overall nutritional status of our most robust measure, weight-for-age, does appear to have improved by endline, but was similar in the two study arms, suggesting no additional benefit of the LNS. While the odds of clinical malaria among those who received the intended intervention were lower in each study arm compared to children who did not receive interventions (SP-AQ only OR = 0.23 [0.09-0.6]; SP-AQ plus LNS OR = 0.22 [0.09-0.55]), LNS was not shown to have an additional impact. Coverage of SMC was high regardless of integrating LNS delivery into the SMC campaign. Supplementation with LNS did not appear to impact nutritional outcomes, but appeared to enhance the impact of SP-AQ on clinical odds of malaria. These results indicate that combining nutritional interventions with seasonal malaria chemoprevention in high-risk areas can be done successfully, warranting further exploration with other products or dosing. Trial Registration: ISRCTN 11413895.

中文翻译：

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尼日利亚北部季节性疟疾的化学预防与营养不良的预防结合：一项套用病例对照的实用试验（SMAMP研究）。

自2012年以来，世卫组织建议将季节性疟疾化学预防（SMC）与营养干预措施相结合，以预防疟疾感染，并与营养干预措施相结合，可改善健康状况并提高运营效率。这项研究评估了联合包装干预措施对尼日利亚北部地区的分布范围，营养和疟疾临床效果的影响。2014年8月至2014年11月，社区志愿者每月在尼日利亚卡诺州Madobi的七个病区向约7,000名6-24个月大的儿童提供门到门的磺胺多辛-乙胺嘧啶和阿莫二喹（SP-AQ）。在三个病房中，儿童还接受了一种基于脂质的营养补充剂（中等量的LNS），Plumpy Doz。覆盖范围，依从性和人体测量结果通过基线，中线和最终家庭住户调查进行评估。还进行了一项基于设施的病例对照研究，以评估其对临床疟疾结局的影响。两支SP-AQ的覆盖率相似，仅SP-AQ的一组为89％（n = 2409个孩子-月[88-90％]），而两支之间的SP-AQ的覆盖率相似（90％（n = 1947个孩子-月[88-92％]）在SP-AQ加LNS臂中（p = 0.52）。LNS的覆盖率为83％（n = 2,409个孩子月[81-84％]）。尽管基线，中线和终点之间的人体测量学状态发生了显着变化，但这些变化在很大程度上是由社会经济状况引起的，由于可能存在的测量问题，尤其是基于长度的指标，必须谨慎解释。我们最有效的量度方法（按年龄段体重）的总体营养状况似乎在终末期得到了改善，但在两个研究组中相似，这表明LNS并没有其他益处。与未接受干预的儿童相比，接受研究干预的患儿临床疟疾的几率要低（仅SP-AQ或= 0.23 [0.09-0.6]； SP-AQ加LNS或= 0.22 [ 0.09-0.55]），LNS没有显示出其他影响。无论将LNS交付整合到SMC活动中，SMC的覆盖率都很高。补充LNS似乎并不影响营养结果，但似乎可以增强SP-AQ对疟疾临床几率的影响。这些结果表明，在高风险地区将营养干预与季节性疟疾化学预防相结合可以成功完成，从而有必要与其他产品或剂量一起进行进一步的探索。试用注册：ISRCTN 11413895。