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临床试验/NCT01562379
NCT01562379已完成2 期

Evaluation of Complementary Food Supplements For Reducing Childhood Undernutrition: The JiVitA-4 Study

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 5,449 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
5,449
试验地点
1
主要终点
Stunting in Children at 18 mo

研究概览

简要总结

The purpose of this study is to test the impact on child growth of three specially formulated complementary food supplements vs. Plumpy'Doz, a previously tested, commercially available complementary food, and vs. a control group that receives no food. All groups will receive nutrition education related to infant and young child feeding. This will be a cluster-randomised trial in children 6-18 months old in rural Rangpur and Gaibandha in Bangladesh.

详细描述

Childhood stunting and growth faltering is highly prevalent in South Asia. Among other strategies, adequate complementary feeding practices and provision of complementary foods that are appropriate and fill the nutrient gap by providing macro and micronutrients essential for growth are important means to reduce the global burden of undernutrition and related morbidity and mortality.

We propose to evaluate the impact of three complementary food supplement products that are fortified with micronutrients in a rural, remote setting in Bangladesh, where high rates of childhood undernutrition persist on child growth, health, and development. The three foods being tested are an enhanced wheat-soy blend (WSB++) developed by WFP, and locally developed chickpea-based and a rice-based complementary food supplements.

We will assess the impact of feeding these daily against the non-fed controls, hypothesizing that the children fed these foods show increased length for age Z scores (LAZ) and weight for length age Z scores (WLZ) of >0.21 and decreased prevalence of stunting and wasting by >10%. We expect that the impact of the three foods will be equivalent/ non-inferior to that of Plumpy'Doz.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 8 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants 6 months of age

排除标准

  • 未提供

研究组 & 干预措施

No food

No Intervention

A control in which mothers will receive nutrition education about continued breastfeeding and adequate complementary feeding throughout the period of 6-18 months of age.

Plumpy Doz

Active Comparator

In this control arm children will receive prepackaged, lipid-based Plumpy'Doz (Nutriset, Mulaunay, France) for daily consumption as a snack.

干预措施: Plumpy Doz (Dietary Supplement)

Wheat Soy Blend (WSB++)

Experimental

Children will receive a WFP-developed Wheat-Soy Blend (WSB++) snack to be consumed daily.

干预措施: Wheat Soy Blend (WSB++) (Dietary Supplement)

Chickpea based complementary food supplement

Experimental

Children will receive a Chickpea based complementary food supplement to be consumed daily.

干预措施: Chickpea based complementary food supplement (Dietary Supplement)

Rice based complementary food supplement

Experimental

Children will receive a locally developed rice based complementary food supplement.

干预措施: Rice based complementary food supplement (Dietary Supplement)

结局指标

主要结局

Stunting in Children at 18 mo

时间窗: 18 months of age

Prevalence of stunting at 18 months of age.

次要结局

  • Morbidity(weekly from 6 to 18 months of age)
  • Intestinal Function(At 24 months of age)
  • Developmental Milestones(At 6, 12, and 18 months of age)
  • Micronutrient Status(18 months of age)
  • Cognitive and Motor Function(At 18 months of age)
  • Body Composition(At 6, 9 and 12 months of age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Parul Christian

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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