Seasonal Impact of Iron Fortification on Malaria Incidence in Ghanaian Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,880
- 试验地点
- 2
- 主要终点
- incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)
研究概览
简要总结
Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. The impact of severe IDA can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas.
The primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area.
The value of performing this research in Ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.
详细描述
Study Design:
The proposed study is a community-based blinded randomized controlled trial with 2 study arms that will be conducted in two phases:
- Phase I will take place during the dry season (December to April), when malaria transmission rates are lower. Eligible subjects (one per household) will be individually randomized to receive a daily dose of either a powdered vitamin/mineral fortificant containing 12.5 mg of iron (plus ascorbic acid, vitamin A and zinc), or a placebo (containing all micronutrients excluding iron), added to complementary foods, for 5 months.
- Phase II will take place during the wet season (June to October), when malaria transmission rates are higher. Eligible subjects, who did not participate in Phase I, will be individually randomized to one of the two study arms as described above and followed for 5 months.
A dual phase design, with two unique cohorts, was chosen so that preliminary results (at the end of phase 1) could be assessed by an independent Data Safety and Monitoring Committee. It is possible that during the dry season no impact of iron will be detected, while during the wet season, an impact will be observed. With this possible outcome, it is potentially feasible to translate this knowledge into a Ministry of Health Program to only provide iron supplementation (fortification) during the dry months of the year (December to April).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-24 months
- •Ingesting weaning food in addition to breastmilk
- •Free from malaria or other major illnesses
- •Living in Brong Ahafo Region of Ghana for duration of intervention and follow-up
排除标准
- •Severe anemia (hemoglobin <70g/L)
- •Weight-for-height <-3 z-score(severe wasting)
- •Kwashiorkor (defined as evidence of edema)
- •Congenital abnormality
- •Treatment with iron supplements within the past 6 months
- •Presence of any chronic illness
结局指标
主要结局
incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count)
时间窗: 5 months
次要结局
- severity of clinical malaria (blood parasite count)(5 months)
- cerebral malaria (defined by a parasite count >5000/μL blood and a concurrent score of <2 on the Blantyre coma scale, with or without convulsions)(5 months)
- changes in anemia status (blood levels of: haemoglobin(Hb) , ferritin (SF))(5 months)
- hospitalization (documentation of hospitalization for any reason)(5 months)
- death(5 months)
- pneumonia (defined by the presence of a cough or breathing difficulties, tachypnea, lower chest wall indrawing, and the appearance of consolidation or pleural effusion on a chest X-ray)(5 months)
- diarrhea (defined by >3 loose or watery stools in the previous 24 hours)(5 months)
- dehydration (defined by lethargy, sunken eyes, and decreased skin turgor [>2 seconds for skin to return following a skin pinch])(5 months)
研究者
Stanley Zlotkin
Chief, Global Child Health
The Hospital for Sick Children