A Randomised Trial to Assess the Safety and Efficacy or Iron Supplementation in Kenyan Pregnant Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- Maternal Plasmodium infection
研究概览
简要总结
The purpose of this study is to compare the presence of Plasmodium infection in parturient women who antenatally received a combination of iron-fortified foods with iron supplements versus iron-fortified foods only.
详细描述
As per recommendations by the World Health Organization (WHO), iron supplementation in children should be restricted in malaria-endemic areas because of concerns that it can lead to an increased burden of malaria. Universal iron supplementation continues to be recommended, however, for women during pregnancy and 3 months postpartum. Observational studies have shown that iron deficiency in parturient women is associated with a marked reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium infections in pregnant women have devastating effects on the foetus and neonate, causing low birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion, stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is currently drafting legislation for mandatory iron fortification of industrially milled flour. Implementation of the new fortification policy means that pregnant women will receive iron through a combination of fortified foods and supplementation. The investigators are concerned about the safety of the high iron intake resulting from such a policy.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 15-45 years resident in the predefined study area
- •Pregnant, with gestational age <23 weeks
排除标准
- •Failure to provide a blood sample
- •Initial haemoglobin concentration <90 g/L
- •Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes
- •Obstetric history suggestive of eclampsia or pre-eclampsia
- •Obvious mental retardation or metabolic disorder;
- •No written consent
- •Carrying multiples
- •Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter
- •Woman planning to deliver outside the research clinic.
结局指标
主要结局
Maternal Plasmodium infection
时间窗: Parturition
Assessed by LDH- and HRP2-based dipstick test and PCR
次要结局
- Serum non-transferrin bound iron concentration(3 h after ingestion of first supplement with either iron or placebo)
- Neonatal iron stores(At 1 month of age)
- Maternal iron status(At 1 month after delivery)
- Maternal intestinal pathogens(At 1 month after delivery)