A multi-country, randomized trial of three nutritional supplements on short-term and sustained anthropometric recovery in children 6-24 months of age with moderate wasting and acute illnesses: the NUTRIMAM study protocol.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-11-05 DOI:10.1186/s13063-024-08390-5
{"title":"A multi-country, randomized trial of three nutritional supplements on short-term and sustained anthropometric recovery in children 6-24 months of age with moderate wasting and acute illnesses: the NUTRIMAM study protocol.","authors":"","doi":"10.1186/s13063-024-08390-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Globally, moderate wasting affects approximately 33 million children. Complex bidirectional interactions exist between wasting and infection in children. Children who experience both conditions have an increased risk of adverse outcomes including progression to severe wasting and mortality. Breaking the cycle between moderate wasting and infection could help improve growth and survival in these children. The NUTRIMAM trial will aim to investigate the efficacy of a 12-week regimen of three different nutritional interventions in at-risk young children (i.e., children who are moderately wasted and have one/more acute infections) on anthropometric recovery. Further, the study will explore whether recovery can be sustained with a post-intervention package that includes counseling and food vouchers. Sustaining anthropometric recovery beyond supplement administration will have important implications for programs.</p><p><strong>Methods: </strong>NUTRIMAM is a multi-country, multi-center individually randomized, open-label, trial in five countries including Bangladesh, India, Mali, Pakistan, and Tanzania. A total of 6360 moderately wasted children aged 6 to 24 months with acute illness will be enrolled at health centers. Children will be randomly allocated to receive one of three dietary supplements (locally available foods, ready-to-use supplementary foods, or microbiota-directed supplementary foods) for 12 weeks. Anthropometric recovery will be assessed over this period. Participants who recover will then be re-randomized to a post-recovery support intervention comprising either counseling and food vouchers or routine standard of care for recovered children for an additional 12 weeks to determine if this intervention facilitates sustained recovery at 24 weeks.</p><p><strong>Discussion: </strong>Children who are moderately wasted and have an infection are at higher risk of adverse outcomes. There are very few clinical trials that have been performed among children with moderate wasting with infectious illnesses to investigate if it is possible to break the undernutrition-infection cycle and thereby reduce the risk of nutritional deterioration to severe wasting or mortality and decrease the risk of acute infections. The results of the trial are anticipated to fill important evidence gaps in feeding recommendations for moderately wasted children with acute illness as well as interventions to sustain anthropometric recovery in children beyond the period of the nutritional intervention.</p><p><strong>Trial registration: </strong>ISRCTN registry, ISRCTN53213318 . Registered on April 03, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536563/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-024-08390-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Globally, moderate wasting affects approximately 33 million children. Complex bidirectional interactions exist between wasting and infection in children. Children who experience both conditions have an increased risk of adverse outcomes including progression to severe wasting and mortality. Breaking the cycle between moderate wasting and infection could help improve growth and survival in these children. The NUTRIMAM trial will aim to investigate the efficacy of a 12-week regimen of three different nutritional interventions in at-risk young children (i.e., children who are moderately wasted and have one/more acute infections) on anthropometric recovery. Further, the study will explore whether recovery can be sustained with a post-intervention package that includes counseling and food vouchers. Sustaining anthropometric recovery beyond supplement administration will have important implications for programs.

Methods: NUTRIMAM is a multi-country, multi-center individually randomized, open-label, trial in five countries including Bangladesh, India, Mali, Pakistan, and Tanzania. A total of 6360 moderately wasted children aged 6 to 24 months with acute illness will be enrolled at health centers. Children will be randomly allocated to receive one of three dietary supplements (locally available foods, ready-to-use supplementary foods, or microbiota-directed supplementary foods) for 12 weeks. Anthropometric recovery will be assessed over this period. Participants who recover will then be re-randomized to a post-recovery support intervention comprising either counseling and food vouchers or routine standard of care for recovered children for an additional 12 weeks to determine if this intervention facilitates sustained recovery at 24 weeks.

Discussion: Children who are moderately wasted and have an infection are at higher risk of adverse outcomes. There are very few clinical trials that have been performed among children with moderate wasting with infectious illnesses to investigate if it is possible to break the undernutrition-infection cycle and thereby reduce the risk of nutritional deterioration to severe wasting or mortality and decrease the risk of acute infections. The results of the trial are anticipated to fill important evidence gaps in feeding recommendations for moderately wasted children with acute illness as well as interventions to sustain anthropometric recovery in children beyond the period of the nutritional intervention.

Trial registration: ISRCTN registry, ISRCTN53213318 . Registered on April 03, 2023.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
关于三种营养补充剂对 6-24 个月中度消瘦和急性病儿童短期和持续人体测量恢复的多国随机试验:NUTRIMAM 研究方案。
背景全球约有 3300 万儿童患有中度消瘦症。儿童消瘦和感染之间存在着复杂的双向相互作用。同时经历这两种情况的儿童出现不良后果的风险会增加,包括发展为严重消瘦和死亡。打破中度消瘦与感染之间的循环有助于改善这些儿童的生长和生存状况。NUTRIMAM 试验旨在研究对高危幼儿(即中度消瘦并患有一种/多种急性感染的儿童)进行为期 12 周的三种不同营养干预对人体测量恢复的疗效。此外,该研究还将探讨干预后的一揽子方案(包括咨询和食品券)是否能使恢复得以持续。在服用补充剂后,维持人体测量的恢复将对项目产生重要影响:NUTRIMAM 是一项在孟加拉国、印度、马里、巴基斯坦和坦桑尼亚等五个国家开展的多国、多中心、单独随机、开放标签试验。共有 6360 名年龄在 6 到 24 个月之间、患有急性病的中度消瘦儿童将在医疗中心登记。儿童将被随机分配接受三种膳食补充剂(当地食品、即食补充剂或微生物指导补充剂)中的一种,为期 12 周。在此期间将对人体测量恢复情况进行评估。恢复后的参与者将被重新随机分配到恢复后支持干预中,包括咨询和食品券或为恢复后的儿童提供常规标准护理,为期 12 周,以确定这种干预是否有助于 24 周后的持续恢复:中度消瘦和感染的儿童出现不良后果的风险较高。目前很少有临床试验针对中度消瘦并患有感染性疾病的儿童,研究是否有可能打破营养不良-感染的循环,从而降低营养恶化至严重消瘦或死亡的风险,并降低急性感染的风险。预计试验结果将填补在急性病中度消瘦儿童喂养建议方面的重要证据空白,以及在营养干预期后维持儿童人体测量恢复的干预措施方面的重要证据空白:ISRCTN注册,ISRCTN53213318。注册日期:2023 年 4 月 3 日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
期刊最新文献
Implementing palliative care in hepatocellular carcinoma ambulatory clinics-study protocol for Accelerated translational research in PRImary liver CAncer (APRICA) randomised controlled palliative care trial. A website for cluster randomised trials including stepped wedge: facilitating quality trials and methodological research. Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial. What motivates SARS-CoV-2 vaccine trial participants? A pre- and post-participation survey study. A multi-country, randomized trial of three nutritional supplements on short-term and sustained anthropometric recovery in children 6-24 months of age with moderate wasting and acute illnesses: the NUTRIMAM study protocol.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1