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临床试验/NCT00255385
NCT00255385已完成3 期

Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2002年4月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
1,200
试验地点
2
主要终点
Diarrhea

研究概览

简要总结

The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.

详细描述

The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of "disability adjusted life years" (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys & girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the "World Summit for Children" set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.

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
Double

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 12-36 months at enrollment
  • Resident of Sangam Vihar and likely to be in the area for 1 year.
  • Parents consenting to participate in the trial.

排除标准

  • Children who have been given complete therapeutic/preventive course of Iron in the last 6 months.
  • Children currently as part of a different Iron/Zinc supplementation program.
  • Children known to be allergic to milk.
  • Children who are severely malnourished and requiring hospitalization.

结局指标

主要结局

Diarrhea

Pneumonia

Febrile illness

Activity

Growth

Development

次要结局

  • Iron status
  • Zinc status
  • Colonization
  • Copper status

研究者

研究点 (2)

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