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Ischaemic stroke – Vitamin D doubled survival (Injection and 60,000 IU per month) – RCT Aug 2016

Effect of Vitamin D and calcium supplementation on ischaemic stroke outcome: a randomised controlled open-label trial

International Journal of Clinical Practice , Early View, DOI: 10.1111/ijcp.12866
Anu Gupta, Sudesh Prabhakar, Manish Modi, Sanjay K Bhadada, Mani Kalaivani, Vivek Lal, Dheeraj Khurana


Background and aims
Vitamin D deficiency is a common problem in stroke survivors. Observational studies have reported an association of low vitamin D levels with greater stroke severity, poststroke mortality and functional disability. Randomised clinical trials are lacking. We sought to assess the effect of calcium and vitamin D supplementation in ischaemic stroke survivors with vitamin D deficiency/insufficiency on disability/mortality outcomes.

Methods
In this randomised controlled open-label trial, 73 patients of acute ischaemic stroke were screened for serum 25 hydroxy Vitamin D (25(OH)D) levels. A total of 53 patients with baseline 25(OH)D <75 nmol/L were randomised into two arms. One received vitamin D and calcium supplementation along with usual care (n=25) and the other received usual care alone (n=28). Primary outcome was the proportion of patients achieving a good outcome [modified Rankin Scale score 0–2] at 6 months and all cause mortality at 6 months.

Results
The age (mean±SD) of participants was 60.4±11.3 years, 69.8% were males. The proportion of patients achieving good outcome was higher in the intervention arm (Adjusted OR 1.9, 95% CI 0.6–6.4; P=.31). The survival probability was greater in the intervention arm (83.8%, CI 62.4–93.6) as compared with the control arm (59.5%, CI 38.8–75.2; P=.049) with adjusted Hazard ratio (HR) of 0.26 (95% CI 0.08–0.9; P=.03).

Conclusions
This is the first randomised controlled study assessing the effect of vitamin D and calcium supplementation on ischaemic stroke outcomes and points towards a potential benefit. Findings need to be validated by a larger trial.

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PDF also available for free at Sci-Hub

From PDF

  • The intervention group received a single intramuscular injection of 600 000 IU cholecalciferol followed by oral cholecalciferol 60 000 IU once a month with one gram elemental calcium daily along with usual poststroke care.
  • Death rate
    16% if supplemented
    39% in the usual care arm.
  • Survival probability at 6 months
    84% if supplemented
    60% in usual care arm
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