A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition (Njugu Plus)
2014年8月15日 更新者：University of Oxford
A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition.
The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.
研究概览
地位
完全的
条件
详细说明
Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.
Description of Study Design: Randomized Controlled Trial
Study Duration: 6 months (Trial); 12 months (All trial-related activities)
Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.
Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.
Location: Kilifi District, coastal Kenya.
研究类型
介入性
注册 (实际的)
60
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Coast
-
Kilifi、Coast、肯尼亚、80108
- Kilifi District Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6个月 至 5年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Children aged 6 months to 5 years old
- Provision of informed consent
- Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema)
- Stabilised and eligible to receive RUTF according to national guidelines
Exclusion Criteria:
- Known HIV disease, tuberculosis or other chronic infection*
Known allergy or hypersensitivity to any of the product ingredients
- Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Standard RUTF
Standard RUTF given according to National Guidelines
|
Standard formulation RUTF given according to National Guidelines
|
|
实验性的：RUTF/Flax Oil
RUTF/Flax Oil is reformulated RUTF to increase n3 content
|
Ready to Use Therapeutic Food
|
|
实验性的：RUTF/Flax Oil plus additional Fish Oil
RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3.
Fish oil to provide long chain n3
|
Ready to Use Therapeutic Food
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total long chain PUFA in erythrocyte membranes at 3 months
大体时间：3 months
|
Total long chain PUFA in erythrocyte membranes at 3 months
|
3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
大体时间：3 months
|
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
|
3 months
|
|
Total long chain PUFA in CD3 cell membranes at 3 months
大体时间：3 months
|
Total long chain PUFA in CD3 cell membranes at 3 months
|
3 months
|
|
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
大体时间：3 months
|
Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
|
3 months
|
|
Total long chain PUFA in plasma at 3 months
大体时间：3 months
|
Total long chain PUFA in plasma at 3 months
|
3 months
|
|
Ratio of n-6:n-3 PUFA in plasma at 3 months
大体时间：3 months
|
Ratio of n-6:n-3 PUFA in plasma at 3 months
|
3 months
|
|
Change in weight for height z score between baseline and 3 months
大体时间：3 months
|
Change in weight for height z score between baseline and 3 months
|
3 months
|
|
Change in mid upper arm circumference between baseline and 3 months
大体时间：3 months
|
Change in mid upper arm circumference between baseline and 3 months
|
3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：James A Berkley, FRCPCH、KEMRI-Wellcome Trust Collaborative Research Program
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年5月1日
初级完成 (实际的)
2013年8月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2012年5月4日
首先提交符合 QC 标准的
2012年5月7日
首次发布 (估计)
2012年5月8日
研究记录更新
最后更新发布 (估计)
2014年8月18日
上次提交的符合 QC 标准的更新
2014年8月15日
最后验证
2014年8月1日
更多信息
与本研究相关的术语
其他研究编号
- SSC 2157
- OPP1046183 (其他赠款/资助编号：The Bill & Melinda Gates Foundation)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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-
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-
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