The effect of Vitamin D3 on clinical outcome of stroke patients in ICU- a prospective randomised double blind study
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
Dr Akrity Singh
Indira Gandhi Institute of Medical Sciences
