Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
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
- 否
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
Victor Alfonso Mayen
Nutritionist, Magister Science
Association for the Study and Prevention of HIV/AIDS
