Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
研究概览
简要总结
The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.
详细描述
Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.
Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.
This study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.
This specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group.
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
- Single
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-18 months of age
- •anemic (Hb 70-100g/L)
- •ingesting weaning food in addition to breast milk
- •free from major illness (including symptomatic for malaria) and afebrile
- •living within study area for the next two months
- •parental consent obtained
- •only one child per household in the study
排除标准
- •Hb < 70 or ≥ 100 g/L
- •Not receiving any complementary foods
- •Receiving an iron supplement within two weeks of the date of enrolment
- •chronic illness
- •severely malnourished: weight for age z-score < -3.0
- •another child in the household is a subject in this study
结局指标
主要结局
Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing
次要结局
- Ferritin at 8 weeks
- Serum Transferrin Receptor (sTfR) at 8 weeks
- side effects every 2 weeks
- compliance with iron supplement assessed every 2 weeks
研究者
Stanley Zlotkin
Chief, Global Child Health
The Hospital for Sick Children