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临床试验/CTRI/2020/11/028999
CTRI/2020/11/028999已完成不适用

A double blinded randomized controlled trial to compare the effectiveness of oral multiple micronutrient supplement Vs oral iron and folic-acid, for anemia prophylaxis among non-anemic pregnant women in rural Haryana.

Dr Anjusha Ranjith1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Change in hemoglobin level

研究概览

简要总结

This study is a double blinded, parallel group, non-inferiority randomized controlled trial comparing the safety and efficacy of oral multiple micronutrient supplement 1 tablet daily and oral iron and folic-acid supplement 1 tablet daily for 180 days in 200 non-anemic pregnant women, that will be conducted in 6 subcentres under PHC Chhainsa and 6 subcentres under PHC Dayalpur in Haryana, India. The primary outcome measure will be change in hemoglobin level after 180 days of supplementation. The secondary outcomes will be change in serum ferritin levels , serum Vitamin B-12 levels and serum folate levels after 180 days of supplementation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • (1) Pregnant women less than or equal to 12 weeks of gestation, (2) non-anemic with hemoglobin value between 11 g/dl and 14 g/dl, (3) those who are willing to stay at the current address during their entire pregnancy.

排除标准

  • (1) If taking iron supplements for more than 1 month or received intravenous iron/ blood transfusion in the past 6 months, (2) diagnosed hypertension, overt diabetes, multiple pregnancy, (3) patient diagnosed with an illness which can alter the hemoglobin values including malabsorption, hemoglobinopathies, hemorrhage in the last 1 month etc., (4) diagnosed psychiatric illness.

结局指标

主要结局

Change in hemoglobin level

时间窗: 180 days

次要结局

  • Change in serum folate(180 days)
  • Change in serum ferritin(180 days)
  • Change in serum Vitamin B-12(180 days)

研究者

发起方
Dr Anjusha Ranjith
申办方类型
Other [self]

研究点 (1)

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