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临床试验/CTRI/2025/12/098728
CTRI/2025/12/098728尚未招募4 期

The effect of Vitamin D3 on clinical outcome of stroke patients in ICU- a prospective randomised double blind study

Indira Gandhi Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1

研究概览

简要总结

Rationale- Recently, vitamin D3 has emerged as a potential treatment adjunct for ischemic stroke, as it interferes with the key to survival pathways and shows neuroprotective, anti-inflammatory, regenerative and anti-aging properties in both neuronal and vascular tissue. Past studies on oral and IM supplementation of vitamin D shows mixed results, now IM single dose of vitamin D is available and has not been tested yet. We hypothesise that IM vitamin D3 may have better outcome in quality of stroke patients. Novelty-of our study is the use of single shot IM vitamin D3 , which will have more predictable and effective results. Primary Objective- comparison of modified Rankin scale at 90 days of admission to ICU between the two groups (IV vitamin D and placebo) Secondary objectivecomparison of modified Rankin scale at the time of discharge, Number of days of mechanical ventilation, Change in serum vitamin D3 from baseline to Day5. Methods-upon admission all stroke patients will be assessed on the basis of National institute of health stroke scale (NIHSS). patients with baseline NIHSS score between 5-24 will be included in study and their serum Vitamin D levels will be assessed and IM VitD3 injection of 600000 IU will be given to those with levels less than 30ng/ml. Outcome- will be better neurological outcome in terms of functional ability and disability free days by the neuroprotective and neuro-modulatory effects.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 18-75 years Patients of both sex Patients admitting to ICU with cerebrovascular stroke both ischemic and haemorrhagic with NIHSS score 5-24 ,diagnosis confirmed with CT/MRI.

排除标准

  • patients with vitamin D more than 30ng/ml patients on vitamin D supplementation patients with traumatic brain injury.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Akrity Singh

Indira Gandhi Institute of Medical Sciences

研究点 (1)

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