The effect of vitamin D on COPD exacerbation: a double blind randomized placebo-controlled parallel clinical trial.

Mojgan Sanjari,Akbar Soltani,Maryam Zareinejad,Abdolrahim Habibi Khorasani

doi:10.1186/s40200-016-0257-3

Abstract

BackgroundTo investigate the effect of supplementation of standard treatment (inhaled long-acting β2 agonists, anticholinergics and corticosteroids) with vitamin D on C reactive protein and pulmonary function tests in patients with COPD exacerbation.Methods Design: Randomized, single-center, double-blind, placebo-controlled parallel trial. One teaching hospital Participants: 135 patients in pulmonary ward with moderate to severe COPD and exacerbations.120 patients fulfilled the study protocol. Interventions: Patients were randomly divided into three groups receiving 7 day treatment with 0.25 μg calcitriol daily (n = 45), 50000 IU daily of vitamin D (n = 45) or placebo (n = 45). An independent nurse was responsible for allocation, preparation, and accounting of trial medications. Main Outcome measures: Maximal expiratory flow volume (FEV1) and forced volume capacity curves (FVC) and Modified Medical Research Council (MMRC) scale.ResultsOut of 135 patients who were recruited consecutively, 45 patients randomly were randomly assigned in three groups (balance blocked randomization.15 patients were dropped out due to non-compliance for second PFT. Intention to treat analysis was carried out for 120 participants. The difference between before and after treatment FEV1 and FEV1/FVC ratio had no significant difference between treatment groups and placebo. (P = 0.43, P = 0.51, respectively)but clinical improvement was significant in patients who received calcitriol. No side effects were reported.ConclusionsShort term treatment with either calcitriol or 25(OH) 2Vit D didn’t changed FEV1 or FVC in vitamin D sufficient patients with COPD exacerbation; nevertheless it can provide clinical benefit.Trial registrationTrial registration: Iranian Registry of Clinical Trials no. IRCT138712271774N1. Registered 10 April 2011.

Highlights

To investigate the effect of supplementation of standard treatment with vitamin D on C reactive protein and pulmonary function tests in patients with Chronic obstructive pulmonary disease (COPD) exacerbation
Some studies have found the effect of exacerbations on disease progression, which can be manifested by accelerated forced expiratory volume in one second (FEV1), and reduced characteristic of COPD [10, 11]
The aim of this study is to evaluate the role of exogenous addition of vitamin D and 1, 25 dihydroxy vitamin D on the function of lung in the patients suffering from COPD exacerbation

Summary

Introduction

To investigate the effect of supplementation of standard treatment (inhaled long-acting β2 agonists, anticholinergics and corticosteroids) with vitamin D on C reactive protein and pulmonary function tests in patients with COPD exacerbation. Many studies have shown 25-OHD serum levels in patients suffering from COPD. Vitamin D deficiency in African-Americans is closely associated with higher susceptibility to COPD [2, 3]. The VDR levels is significantly low in lung tissues of COPD patients [5]. Studies have found a linear correlation between higher risks of vitamin D deficiency in patients with COPD and the function of lung and systemic levels of vitamin [7, 8]. The symptoms of exacerbations are normally severe deterioration of symptoms, intense airway inflammation and physiological worsening [9]. They are assumed to act as a reference in the therapeutic study of COPD. Exacerbations is estimated to be the cause of nearly 25 % of the FEV1 decline in COPD [10]

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