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
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The effect of Parietene self-fixing semi-resorbable mesh on inguinal pain developmentInguinal hernia, mesh, chronic painHernia inguinalis, mesh, chronische pijnNL-OMON25668MJA Loos MDDepartment of SurgeryMaxima Medical CentreDe Run 4600, 5500 MB Veldhoven, the Netherlands350
尚未招募
4 期
Comparative study of various antihistamines in the treatment of urticariaCTRI/2022/11/047129Meenakshi medical college hospital and research institute
尚未招募
不适用
Randomised controlled double blinded trial of the use of cold scalpel versus cutting diathermy for skin incisions in clean (non-bowel) laparoscopic and open surgerysurgical skin incisions - wound healing and cosmesisSurgery - Surgical techniquesACTRN12609000567224Alfred Health100
尚未招募
Unknown
Effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder paiCTRI/2024/03/063927Dr Nithu Dina Joseph
终止
3 期
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and EntyvioUlcerative ColitisNCT06570772Alvotech Swiss AG301
