Cooking With Iron Ingots: Assessing Feasibility and Natural History Among Infants in Resource-limited Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in hemoglobin over time
研究概览
简要总结
This study evaluates the feasibility of cooking with an iron ingot, Lucky Iron Fish™ (LIF), and evaluate the natural history of hemoglobins and iron status among infants of families using this iron ingot in a population with a high prevalence of iron-deficiency anemia. Participants are mother-infant dyads, and are randomized to one of two arms: Lucky Iron Fish™or enhanced standard of care.
详细描述
Iron deficiency and iron-deficiency anemia contribute significantly to global pediatric morbidity, predominantly affecting women and preschool aged children in resource-limited settings. Iron-deficiency in infancy has been linked to neurodevelopmental delay.
Current methods of iron repletion and supplementation have proved inadequate. The Lucky Iron Fish™ is a iron ingot, the size of a small bar of soap, that is made of pure iron. When boiled, it releases bioavailable iron into water, which is then used for food preparation and/or drinking. Participants in the LIF arm are instructed to acidify the water with citrus juice (provided).
All participants are followed at the same intervals to complete questionnaires and study-related labs.
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, Investigator)
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother ≥ 18 years of age
- •A newborn delivered at ≥ 35 weeks
- •Infant Child followed by (or will be followed by) affiliated clinic (Niños Primeros en Salud [NPS]) OR Infant delivered at Angel Ponce, the local maternity hospital of Consuelo, Dominican Republic.
- •Mother is Spanish speaking
- •Mother permission is provided (informed consent)
排除标准
- •Maternal history of Sickle Cell Disease (homozygous)
- •Concurrent enrollment in related study of LIF on anemia of young children (CHOP study #16-012631).
- •Inability to understand and speak Spanish
- •Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions
结局指标
主要结局
Change in hemoglobin over time
时间窗: 6-months and 12-months
Investigators will assess changes in hemoglobin within each study arm and compare hemolgobin levels between study arms (intervention vs. standard of care). Hemoglobin will be measured in grams per deciliter (g/dL) and measured at 6-months, and 12-months. If data is normally distributed, a paired/dependent t-test will be used, if non-normal, a non-parametric test like Wilcoxon's Matched pairs test will be used.
次要结局
- Retention(12-months)
- Adherence to iron ingot use(12-months)
- Rates of refusal(12-months)
- Difference in microbiomes and microbiota(12-months)