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临床试验/NCT00967551
NCT00967551已完成3 期

The Impact of the Use of Zinc Supplementation and Other Micronutrients on the Occurence of Diarrhea Diseases and Respiratory Infections in Children of Daycare Centers

Emory University1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
143
试验地点
1
主要终点
Proportion of Children of Diarrhea Episodes

研究概览

简要总结

Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.

详细描述

The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.

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 (Participant, Care Provider)

入排标准

年龄范围
6 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children attending day care

排除标准

  • Chronic medical problems including sickle cell disease, congenital heart disease

结局指标

主要结局

Proportion of Children of Diarrhea Episodes

时间窗: 6 months

Number of children with diarrhea divided by the number of children in the group

次要结局

  • Proportion of Children With Respiratory Infections(6 months)

研究者

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

Conrad R. Cole

Associate Professor

Emory University

研究点 (1)

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