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临床试验/CTRI/2024/05/066892
CTRI/2024/05/066892尚未招募3 期

An open-labelled randomized controlled trial to compare the efficacy of oral Multiple micronutrient powder vs oral Iron and Folic Acid syrup IFAS given daily, for anemia prophylaxis among nonanemic children aged 6-24 months, in a rural population of Haryana, India

Dr Kapil Yadav1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年5月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
Blood Hb level in gm/dl

研究概览

简要总结

This is a parallel group open labelled randomized control trial . This trial will be conducted in the intensive field practice area (IFPA), Ballabgarh , Haryana . Study population will be non- anemic children of age 6-24 months , who have been residents of the study area for at least past 6 months . In intervention arm , children will receive MMP  ( 1 sachet / day ) daily for 3 months duration . In control arm  children will receive oral iron  and folic acid (IFA) syrup ( 1 mg/kg/day) for 3 months duration (1 ml IFA syyrup contains 20 mg  elemental iron and 100mcg folic acid ). After 3 months of intervention , at the endline, we are planning  to assess blood hemoglobin level ingm/dl as the primary outcome , and serum ferritin level in ng/dl and adherence to supplements as the secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 21.00 Month(s)(—)
性别
All

入选标准

  • Children between 6-21 months of age.

排除标准

  • 未提供

结局指标

主要结局

Blood Hb level in gm/dl

时间窗: done at starting of trial and after 3 months of completion of trial .

次要结局

  • 1. Serum ferritin in ng/dl(2. Adherence to supplement)

研究者

发起方
Dr Kapil Yadav
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kapil Yadav

AIIMS, New Delhi

研究点 (1)

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