Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants
Lungwena Child Nutrition Intervention Study 3, LCNI-3. A Single-Centre Intervention Trial in Rural Malawi, Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
研究概览
详细说明
Childhood undernutrition is very common in rural Malawi, like in many other countries in Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy. Therefore, emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition. However, the options for community based approaches are not as developed as those for institutional management of undernutrition.
The present study tests a recently developed nutrient -dense spread, ready-to use- therapeutic food (RUTF), which offers a potential solution to home based nutrition rehabilitation. The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children in Mangochi District, southern Malawi. In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months. Children in group-one (control group) will receive 75g of maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will be delivered to the participant's home at weekly intervals.
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12 and 15 months of age. A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation. A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18 months).
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups. Secondary outcomes include length gain, incidence of moderate underweight, stunting and wasting, cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration. The study will also produce descriptive data on morbidity and intake of breast milk and other foods during the intervention.
研究类型
注册
阶段
- 第三阶段
联系人和位置
学习地点
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Mangochi District
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Mangochi、Mangochi District、马拉维
- College of Medicine, University of Malawi
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed informed consent from at least one guardian
- Ages 5.50 months to 6.49 months
- Availability during the period of the study
- Permanent resident of the area
Exclusion Criteria:
- WHZ < -2.0 z-scores or presence of oedema
- History of peanut allergy
- Severe illness warranting hospital referral
- Concurrent participation of the child in another clinical trial with intervention to the child
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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Weight gain during the 12-month follow-up (in grams)
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次要结果测量
结果测量 |
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Length gain during the study period (cm)
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Cognitive and motor developmental score at the end of trial
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研究期间血液中血红蛋白浓度的变化(g/l)
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研究期间血清铁蛋白浓度的变化(微克/升)
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人体测量指标的平均变化(年龄别体重 z 分数 [WAZ]、身高别体重 z 分数 [WHZ] 和年龄别身高 z 分数 [HAZ])
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Incidence of undernutrition, stunting and wasting (WAZ, WHZ or HAZ < -2.0)
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合作者和调查者
调查人员
- 研究主任:Per Ashorn, MD, PhD、University of Tampere, Medical School
- 首席研究员:Kenneth Maleta, MBBS, PhD、Kamuzu University of Health Sciences
出版物和有用的链接
一般刊物
- Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3.
- Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619. Erratum In: Arch Pediatr Adolesc Med. 2008 Oct;162(10):942.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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