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

International journal of clinical practice
September 1, 2016
Anu Gupta et al. (7 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to assess the effect of calcium and vitamin D supplementation on disability and mortality outcomes in ischemic stroke survivors with vitamin D deficiency/insufficiency.

Results Summary

The study found that patients receiving calcium and vitamin D supplementation had a higher survival probability (83.8% vs. 59.5%) and a trend toward better functional outcomes, though the latter was not statistically significant. The adjusted hazard ratio for mortality was significantly lower in the intervention group (HR 0.26, P=0.03).

Population

Acute ischemic stroke survivors with baseline 25(OH)D levels <75 nmol/L (mean age 60.4 years, 69.8% male).

Effective Dosage

Not specified in the abstract.

Duration

6 months.

Interactions

None mentioned.

Extracted Claims (2)
InterventionDirectionEndpointPopulationDosageImpactClaim #
calcium and vitamin D supplementation
increase
good outcome [modified Rankin Scale score 0-2] at 6 months
ischaemic stroke survivors with vitamin D deficiency/insufficiency
Adjusted OR 1.9, 95% CI 0.6-6.4; P=.31
higher proportion of patients achieving
#1
calcium and vitamin D supplementation
decrease
all cause mortality at 6 months
ischaemic stroke survivors with vitamin D deficiency/insufficiency
83.8% (CI 62.4-93.6) vs 59.5% (CI 38.8-75.2); P=.049; adjusted HR 0.26 (95% CI 0.08-0.9; P=.03)
greater survival probability
#2
Abstract

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.

Medical Subject Headings (MeSH)
Brain IschemiaCalcium, DietaryDietary SupplementsFemaleFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedRisk FactorsStrokeTreatment OutcomeVitamin DVitamin D DeficiencyVitamins
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations41
Citations/Year4.6
Relative Citation Ratio2.04
NIH Percentile75.2%
Research Impact Scores
APT Score0.75
Weight Score1.96
Normalized Score0.66
Related Supplements
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