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Abstract
Background The relationship between asthma and vitamin D deficiency has been known for some time. However, interventional studies conducted in this regard have shown conflicting results.
Objective To evaluate the efficacy of vitamin D supplementation in asthmatic patients in improving the degree of control of asthma.
Methods Randomised, triple-blind, placebo-controlled, parallel-group study in adult asthmatic patients with serum 25-hydroxyvitamin-D3 <30 ng/mL. The intervention group received oral supplementation with 16 000 IU of calcifediol per week, and the control group had placebo added to their usual asthma treatment. The study period was 6 months. The primary endpoint was the degree of asthma control as determined by the asthma control test (ACT). Secondary endpoints included quality of life measured using the mini Asthma Quality of Life Questionnaire, the number of asthma attacks, oral corticosteroid cycles, the dose of inhaled corticosteroids, number of emergency visits, unscheduled consultations with the primary care physician and hospitalisations for asthma.
Results One hundred and twelve patients were randomised (mean age 55 years, with 87 (78%) being women). Of the 112 patients, 106 (95%) completed the trial. Half the patients (56) were assigned to the intervention group and the other half to the control group. A statistically significant clinical improvement was observed in the intervention group (+3.09) compared with the control group (−0.57) (difference 3.66 (95% CI 0.89 to 5.43); p<0.001) as measured using ACT scores. Among the secondary endpoints, a significant improvement in the quality of life was found in the intervention group (5.34), compared with the control group (4.64) (difference 0.7 (95% CI 0.15 to 1.25); p=0.01).
Conclusion Among adults with asthma and vitamin D deficiency, supplementation with weekly oral calcifediol compared with placebo improved asthma control over 6 months. Further research is needed to assess long-term efficacy and safety.
Trial registration number NCT02805907.
- asthma
- asthma pharmacology
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Footnotes
Contributors LS-G and RA-E had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: LS-G, RA-E and FI-G. Acquisition, analysis, or interpretation of data: LS-G, LS-G, FI-G and MC-M. Drafting of the manuscript: LS-G, RA-E and FI-G. Critical revision of the manuscript for important intellectual content: LS-G, RA-E and FI-G. Statistical analysis: LS-G and RA-E.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Disclaimer The researchers of the study have not received any funding. The only contribution has been made by the pharmaceutical company FAES FARMA, which provided the ampoules of vitamin D and placebo so that the study could be carried out without influencing the development or analysis of the results obtained from the study.
Competing interests All authors have completed and submitted the ICMJE for disclosure of potential conflict of interest. Outside the submitted work, RA-E reports personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Chiesi, personal fees and non-financial support from Orion Pharma, personal fees and non-financial support from MundiPharma, personal fees and non-financial support from Novartis, personal fees and non-financial support from Menarini, personal fees and non-financial support from FAES Pharma, personal fees from Ferrer, personal fees and non-financial support from Zambon. Outside the submitted work, LS-G reports personal fees and non-financial support from Lilly, personal fees and non-financial support from Novo Nordisk, personal fees from AstraZeneca, personal fees and non-financial support from Sanofi, personal fees from Lacer, personal fees from Casen Recordati, personal fees and non-financial support from Jansen-Cilag, personal fees and non-financial support from Nutricia, personal fees and non-financial support from Nestlé, personal fees from Abbott and personal fees and non-financial support from Fresenius-Kabi. Outside the submitted work, FI-G reports non-financial support from Novo Nordisk, personal fees and non-financial support from Lilly, personal fees and non-financial support from Sanofi, personal fees from Abbott and personal fees from AstraZeneca. MC-M reports personal fees from AstraZeneca and Chiesi. CH-Y reports personal fees from Boehringer Ingelheim, outside the submitted work.
Patient consent for publication Not required.
Ethics approval The study was approved by Morales Meseguer Hospital’s ethics committee for clinical research on 29 April 2015 (approval number 18/15).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as online supplemental information. The analysed data included the patients included in the study. All relevant data have been published in this article.