跳至主要内容
临床试验/NCT02257762
NCT02257762Unknown不适用

Efficacy 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 487 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
487
试验地点
1
主要终点
Nutritional status

研究概览

简要总结

The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months in preventing growth faltering and improving micronutrient status. The impact of product will be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.

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 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 moderate acute malnutrition by promoting improved linear growth, weight gain and micronutrient status among children. Until recently, treatment of moderate acute 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 treat and prevent moderate acute 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 growth faltering and improve micronutrient status in Cambodian children.

TRIAL DESIGN AND METHODOLOGY:

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 12 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 6-12 months
  • •Normally nourished or only moderately malnourished (MUAC>115mm, WHZ score>-3)
  • •Have not received therapy for acute malnutrition within one month prior to presentation
  • •Healthy (no ill-health in past two weeks)
  • •Anaemia status - normal, mild or moderate
  • •No known food intolerances
  • •Informed signed consent of caregiver
  • •Caregivers are healthy

排除标准

  • •Children <6 months or >12mths
  • •Severely malnourished (MUAC< 115mm, WHZ score<3, bipedal pitting oedema).
  • •Have received therapy for acute malnutrition within one month prior to presentation
  • •Any medical complications at the recruitment time or illness requiring referral or clinic visit in past 2 weeks
  • •Severe anaemia (Hb<70g/l)
  • •Known intolerances
  • •No informed signed consent of caregiver

研究组 & 干预措施

Lipid-based nutrient supplement (LNS)

Experimental

LNS added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months

干预措施: LNS (Dietary Supplement)

Corn-soy blend ++ (CSB++)

Active Comparator

CSB++ porridge, eaten over 6 months, age 6-12 months to age 11-17 months

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

Sprinkles

Active Comparator

Sprinkles added to borbor, eaten over 6 months, age 6-12 months to age 11-17 months

干预措施: Sprinkles (Dietary Supplement)

Control

No Intervention

Plain borbor and thereafter family foods, eaten over 6 months, age 6-12 months to age 11-17 months

结局指标

主要结局

Nutritional status

时间窗: 6 months

Weight-for-height (WHZ), length/height-for-age (L/HAZ), and weight-for-age (WAZ) calculated through monthly weight and height measurements

次要结局

  • Body composition(6 months)
  • Iron status(6 months)

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)

Loading locations...

相似试验