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临床试验/NCT02257437
NCT02257437已完成不适用

Acceptability of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia

Institut de Recherche pour le Developpement, Cambodia1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Child's consumption

研究概览

简要总结

The purpose of this trial is to evaluate the acceptability of the LNS to women and their children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will be assessed through a sensory test for caregivers, and by measuring children's consumption.

详细描述

BACKGROUND:

In Cambodia, progress in combatting malnutrition has stalled. In 2010, 40% of all children under five (and 49% of 4-5 year-olds) were stunted, 11% were wasted, and 28% were underweight, indicating, respectively, chronic and acute malnutrition, and a combination of the two. Stunting is partially attributed to poor complementary feeding, which remains inadequate for achieving growth outcomes and micronutrient status.

Malnutrition can be prevented and treated with supplementary foods. These foods usually contain a source of protein and lipids such as powered milk, soy or peanuts, and multiple micronutrients. They can be prepared as a fortified blended product, such as Corn-Soy Blend++ (CSB++), that is mixed with water to make a porridge, or ready-to-use supplementary foods (RUSFs). The latter are usually lipid-based nutrient supplements (LNSs) which are often pastes such as the peanut-based Plumpy'Nut™. These energy-dense supplementary foods contain both macro and micronutrients and are used to prevent and treat malnutrition by promoting improved linear growth, weight gain and micronutrient status among children. Until recently, prevention of malnutrition has relied on fortified blended products. The new RUSFs are also proving effective, as they are higher energy and have a longer shelf life, and since they require no preparation, are convenient. Another common nutrition intervention is multiple micronutrient supplements such as Sprinkles. These are individually-packed powders that can be added to food. However, micronutrients are more likely to achieve growth outcomes when they are combined with energy, for example, in lipid-based nutrient supplements and there is no evidence that micronutrient powders alone contribute to growth.

Until June 2014, the United Nations World Food Program (WFP) used CSB++ (now called Supercereal Plus) to prevent malnutrition in Cambodia. Sprinkles are also being distributed, though not widely, to prevent micronutrient deficiencies. These products that have been recently or are currently used are relatively expensive to procure and ship to Cambodia and in the case of Sprinkles, are not as effective as foods that contain macronutrients. Moreover, CSB++ was not very well accepted in practice, and WFP has phased it out. Therefore, UNICEF and the Cambodian Ministry of Health are looking for a locally-produced product containing macro and micronutrients to prevent malnutrition in Cambodia. Locally-produced products are more likely to be acceptable and cheaper than imported products.

Regardless of how effective a product may be, it is vital to determine its acceptability in a given setting, in other words, will a child eat the product and will a caregiver feed it to them. Acceptability to children can be measured by how much they eat and how readily, while acceptability to caregivers is measured in terms of their sensory perception of the food, that is, of the smell, colour, and taste.

研究设计

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

入排标准

年龄范围
9 Months 至 23 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 9-23 months and their caregivers
  • •Have been eating solids for at least three months
  • •Singletons
  • •Normally nourished or only moderately malnourished (MUAC >115mm, WHZ score >-3)
  • •Healthy (no ill-health in past three days)
  • •No known food intolerances
  • •Have not been using Sprinkles, CSB++ or similar supplementary foods or supplements
  • •Informed signed consent of mother
  • •Mothers are healthy

排除标准

  • •Children <9 months or >23mths
  • •Not yet eating solid food for at least three months
  • •Twins/multiples
  • •Severely malnourished (MUAC< 115mm, WHZ score<3, bipedal pitting oedema).
  • •Oedema and/or any medical complications at recruitment or illness requiring referral, or any ill health in past three days.
  • •Known intolerances
  • •Children enrolled in Sprinkles, CSB++ or similar program
  • •No informed signed consent of caregiver
  • •Medical complications or illness requiring referral at time of recruitment or previous two weeks

研究组 & 干预措施

LNS + borbor

Experimental

Lipid-based nutrient supplement (LNS) added to borbor

干预措施: LNS snack (Dietary Supplement)

LNS + borbor

Experimental

Lipid-based nutrient supplement (LNS) added to borbor

干预措施: Corn-soy blend ++ (CSB++) (Dietary Supplement)

LNS + borbor

Experimental

Lipid-based nutrient supplement (LNS) added to borbor

干预措施: Sprinkles (Dietary Supplement)

LNS + borbor

Experimental

Lipid-based nutrient supplement (LNS) added to borbor

干预措施: LNS + borbor (Dietary Supplement)

Corn-soy blend ++ (CSB++)

Active Comparator

CSB++ porridge

干预措施: LNS snack (Dietary Supplement)

Corn-soy blend ++ (CSB++)

Active Comparator

CSB++ porridge

干预措施: Corn-soy blend ++ (CSB++) (Dietary Supplement)

Corn-soy blend ++ (CSB++)

Active Comparator

CSB++ porridge

干预措施: Sprinkles (Dietary Supplement)

Corn-soy blend ++ (CSB++)

Active Comparator

CSB++ porridge

干预措施: LNS + borbor (Dietary Supplement)

Sprinkles

Active Comparator

Sprinkles added to borbor

干预措施: LNS snack (Dietary Supplement)

Sprinkles

Active Comparator

Sprinkles added to borbor

干预措施: Corn-soy blend ++ (CSB++) (Dietary Supplement)

Sprinkles

Active Comparator

Sprinkles added to borbor

干预措施: Sprinkles (Dietary Supplement)

Sprinkles

Active Comparator

Sprinkles added to borbor

干预措施: LNS + borbor (Dietary Supplement)

LNS snack

Active Comparator

LNS eaten as snack

干预措施: LNS snack (Dietary Supplement)

LNS snack

Active Comparator

LNS eaten as snack

干预措施: Corn-soy blend ++ (CSB++) (Dietary Supplement)

LNS snack

Active Comparator

LNS eaten as snack

干预措施: Sprinkles (Dietary Supplement)

LNS snack

Active Comparator

LNS eaten as snack

干预措施: LNS + borbor (Dietary Supplement)

结局指标

主要结局

Child's consumption

时间窗: Within 15 minutes

How much of a given food the children consume

次要结局

  • Child's preference(3 days)
  • Mother's ranking(1 session)

研究者

发起方
Institut de Recherche pour le Developpement, Cambodia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Bindi Borg

PhD Candidate

University of Sydney

研究点 (1)

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