Effectiveness of a reduced dose of ready-to-use therapeutic food in community-based management of severe acute malnutrition: A non-inferiority randomized controlled trial in the Democratic Republic of Congo.

IF 15.8 1区 医学 Q1 Medicine
PLoS Medicine Pub Date : 2025-05-16 eCollection Date: 2025-05-01 DOI:10.1371/journal.pmed.1004606
Julien Ntaongo Alendi, Cécile Salpeteur, Steve Botomba, Alemayehu Argaw, Victor Nikièma, Jean-Baptiste Mayavanga, Benjamin Guesdon, Marie Petry, Uwimana Sebinwa, Sophie Bruneau, Aimée Mupuala Masaya, Florence Mbiya Muadi, Samuel Mampunza Ma Miezi, Marie-Claire Muyer
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引用次数: 0

Abstract

Introduction: The reduced Ready-to-use Therapeutic Food (RUTF) dose strategy was demonstrated effective in recovering children with Severe Acute Malnutrition (SAM) in ideal conditions and in a context of food security. The present study was conducted to provide further evidence on the effectiveness of reduced RUTF dose in a context of high food insecurity and post conflict humanitarian crisis, and with routine health staff.

Methods and findings: An individually randomized non-inferiority trial was conducted in 968 children aged 6-59 months suffering from SAM without medical complications in 14 health centers in the Bonzola and Nzaba health zones of Kasaï Oriental, Democratic Republic of Congo (DRC). Children were randomly assigned to either a control group receiving the standard WHO (World Health Organization) RUTF dose at the time or an intervention group receiving a reduced RUTF dose starting from the third week of treatment. The primary outcome was weight gain velocity from admission to discharge from treatment, while secondary outcomes included anthropometry measurements, programmatic outcomes and relapse. Mixed effects linear and logistic regression models with the health center as random intercept were used to compare differences between the two study groups. Close to 94% of the children were from severely food insecure households. There was no difference in weight gain velocity between the two groups (4.88 ± 2.36 g/kg/d reduced dose group versus 5.09 ± 2.28 g/kg/d standard dose group; difference -0.09 g/kg/d (95% CI [-0.33, 0.15]; p = 0.46). Programmatic outcomes were also similar between the two groups: recovery rate (64.3% versus 67.0%), loss to follow-up (4.69% versus 5.23%), defaulter rate (2.65% and 1.88%), relapse rate over 3 months (2.86% versus 2.40%) and mean length of stay (42 versus 43 days). Nevertheless, the rate of mid-upper arm circumference (MUAC) gain from the third week onwards was lower in the reduced-dose group than in the standard-dose group, with a mean difference of -0.13 mm/week (95% CI [-0.25, -0.01]; p = 0.04). There was no difference in terms of serious adverse events, in the reduced versus standard dose: weight loss (2.24% versus 1.26%), weight stagnation (14.9% versus 17.0%), and medical complications (4.08% versus 3.77%). Important effect modifiers identified were: child sex, child age, season of admission and missed treatment visits.

Conclusions: The strategy of a reduced RUTF dose starting from the third week of treatment is as effective as the standard dose strategy on weight gain velocity and programmatic outcomes in a context of severe food insecurity. However, MUAC gain velocity was lower in the reduced dose group. Future studies should investigate the effectiveness of a reduced dose strategy among sub group of children with high risk factors. Trial registration: International Standard Randomized Controlled Trial Network (ISRCTN15258669).

减少剂量即食食疗食品在社区管理严重急性营养不良中的有效性:刚果民主共和国的一项非劣效性随机对照试验
在理想条件和粮食安全的背景下,减少即食治疗性食品(RUTF)剂量策略被证明对恢复患有严重急性营养不良(SAM)的儿童有效。本研究的目的是提供进一步证据,证明在粮食高度不安全和冲突后人道主义危机的情况下,在常规保健工作人员的帮助下,减少联检工作队剂量的有效性。方法和研究结果:在刚果民主共和国Kasaï东部Bonzola和Nzaba卫生区的14个卫生中心对968名6-59个月无并发症的SAM儿童进行了一项随机非效性试验。儿童被随机分配到当时接受WHO(世界卫生组织)标准RUTF剂量的对照组或从治疗第三周开始接受减少RUTF剂量的干预组。主要结局是入院至出院期间体重增加速度,次要结局包括人体测量、方案结局和复发。以健康中心为随机截距的混合效应线性和逻辑回归模型用于比较两个研究组之间的差异。近94%的儿童来自严重粮食不安全家庭。两组小鼠增重速度无差异(减少剂量组(4.88±2.36 g/kg/d)与标准剂量组(5.09±2.28 g/kg/d);差异-0.09 g/kg/d (95% CI [-0.33, 0.15];p = 0.46)。两组之间的方案结果也相似:恢复率(64.3%对67.0%),随访损失(4.69%对5.23%),违约率(2.65%和1.88%),3个月复发率(2.86%对2.40%)和平均住院时间(42天对43天)。然而,从第三周开始,减少剂量组的中上臂围(MUAC)增加率低于标准剂量组,平均差异为-0.13 mm/周(95% CI [-0.25, -0.01];p = 0.04)。在减少剂量和标准剂量的严重不良事件方面没有差异:体重减轻(2.24%对1.26%),体重停滞(14.9%对17.0%)和医疗并发症(4.08%对3.77%)。确定的重要影响因素有:儿童性别、儿童年龄、入院季节和未就诊。结论:在严重粮食不安全的情况下,从治疗第三周开始减少RUTF剂量的策略与标准剂量策略在体重增加速度和规划结果方面同样有效。而低剂量组MUAC获得速度较低。未来的研究应调查减少剂量策略在具有高风险因素的亚组儿童中的有效性。试验注册:国际标准随机对照试验网络(ISRCTN15258669)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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