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临床试验/NCT04404751
NCT04404751已完成不适用

Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting

Haydom Lutheran Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Haemoglobin level

研究概览

简要总结

Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.

详细描述

Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed anaemic if has HB <11g/dl but in high attitude is =<13g/dl

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)
  • Able to eat food cooked with salt
  • Able to give consent

排除标准

  • Planning to become pregnant within the study period,
  • chronically ill,
  • have haematological diseases during study time,
  • restricted to use salt in food

结局指标

主要结局

Haemoglobin level

时间窗: 10 months of consuming fortified salt

After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt

次要结局

  • Iron store replenishment(10months of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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