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临床试验/CTRI/2024/10/074903
CTRI/2024/10/074903尚未招募4 期

Low versus high oral dose of vitamin B12 for treatment of macrocytic anemia: a randomised controlled trial in a District hospital

Govt Multi speciality hospital sector Chandigarh1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
comparison of change in serum vitamin B12 level after treatment between 2 groups.

研究概览

简要总结

This study will include children from 2 month to 12 years age with vitamin B12 deficiency symptoms or macrocytic picture in peripheral blood film. After confirming vitamin B12 level below threshold the children will be given vit. B12 suppliment for 1 month in 2 groups. 1st group will get low doses of vitamin B12 for 1 month while 2nd group will be supplimented by higher dose of vitamin B12. After 1 month of treatment duration comparison between vitamin B12 level & other hematological parameters will be done, which will help us finding the correct dose for treatment of vitamin B12 deficiency.

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
2.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All children between 2month to 12 years age with vit.
  • B12 deficiency & symptoms will be included.

排除标准

  • Neurological symptoms other than infantile tremor syndrome.
  • Those who have received blood transfusion or vit.
  • B12 therapy upto one month prior to admission.

结局指标

主要结局

comparison of change in serum vitamin B12 level after treatment between 2 groups.

时间窗: At 4 weeks.

次要结局

  • comparison of changes in level of hematological parameters between 2 groups.(1 month)

研究者

发起方
Govt Multi speciality hospital sector Chandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sachin Kumar Singhal

Government Multi Speciality hospital -16 Chandigarh

研究点 (1)

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