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临床试验/NCT01643187
NCT01643187Unknown2 期

Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj

Association for the Study and Prevention of HIV/AIDS1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年7月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
1,000
试验地点
1
主要终点
Change in Nutritional status

研究概览

简要总结

The purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.

详细描述

Chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. It has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. The present study will offer a fortified food, culturally accepted and locally produced. The effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. Both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. This will allow to determine adherence, acceptability, consumption and distribution within the family.

研究设计

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

入排标准

年龄范围
6 Months 至 72 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Some degree of malnutrition according to weight for height or height for age
  • Reside in one of the six communities chosen for the study

排除标准

  • Down syndrome
  • Renal failure

结局指标

主要结局

Change in Nutritional status

时间窗: Months 0, 3, 6, 9, 12 and 15 months

weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance

次要结局

  • Iron Status(Months 0 and 16)
  • Zinc status(Months 0 and 16)

研究者

发起方
Association for the Study and Prevention of HIV/AIDS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victor Alfonso Mayen

Nutritionist, Magister Science

Association for the Study and Prevention of HIV/AIDS

研究点 (1)

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