Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,009
- 试验地点
- 1
- 主要终点
- Severe Anemia
研究概览
简要总结
The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.
详细描述
Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.
Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 45 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with severe anemia (Hb<70g/L)
- •Children 6-24 months with severe anemia (Hb<70 g/L)
排除标准
- •Gestational age >=36 weeks
- •Breathlessness
研究组 & 干预措施
1
Standard of care (Iron-folic acid + Deworming)
干预措施: Iron-folic acid and mebendazole (Dietary Supplement)
2
干预措施: Mebendazole (Drug)
3
干预措施: Multivitamins (Dietary Supplement)
4
干预措施: Mebendazole + Multivitamin (Drug)
结局指标
主要结局
Severe Anemia
次要结局
未报告次要终点
研究者
Parul Christian
Professor
Johns Hopkins Bloomberg School of Public Health
