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临床试验/NCT01553877
NCT01553877已完成2 期

Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
90
试验地点
2
主要终点
Acceptability of at least one Ready -to-Use Complementary Food supplement

研究概览

简要总结

The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.

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
Single (Care Provider)

入排标准

年龄范围
6 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

排除标准

  • loss of appetite,
  • oral lesion,
  • congenital anomaly/acquired disorder affecting growth,
  • severe acute malnutrition (SAM) defined by:
  • MUAC < 115 mm or
  • WL < -3 Z score or
  • bipedal edema,
  • persistent diarrhea,
  • tuberculosis,
  • any other chronic illness.

结局指标

主要结局

Acceptability of at least one Ready -to-Use Complementary Food supplement

时间窗: 7 days

At least one of the experimental Ready -to-Use Complementary Food supplement will be acceptable to the study participants for prevention of malnutrition. The acceptability will be assessed by a 7-point Hedonic scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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