Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hemoglobin
研究概览
简要总结
Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries.
Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013?
Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group.
Design: Randomized clinical trial, triple-blind and placebo-controlled.
Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu.
Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo.
Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Assistance to children's centres full day (8 hours).
- •Age 5 to 59 months.
排除标准
- •Anemia (hemoglobin less than 11 g / dl).
- •Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.
- •Denial for informed consent signing by parents or legal guardians.
- •Diagnosis of severe acute malnutrition by anthropometric measurements.
结局指标
主要结局
Hemoglobin
时间窗: 10 weeks
Hemoglobin quantitation for laboratory tests (g/dl)
次要结局
- Transferrin(10 weeks)
研究者
Cristian Vargas G. MD
Student
CES University