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Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs).
Thorax 2015; 70(5):451-7T

Abstract

RATIONALE

Asthma exacerbations are commonly precipitated by viral upper respiratory infections (URIs). Vitamin D insufficiency associates with susceptibility to URI in patients with asthma. Trials of vitamin D in adults with asthma with incidence of exacerbation and URI as primary outcome are lacking.

OBJECTIVE

To conduct a randomised controlled trial of vitamin D3 supplementation for the prevention of asthma exacerbation and URI (coprimary outcomes).

MEASUREMENTS AND METHODS

250 adults with asthma in London, UK were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 (n=125) or placebo (n=125) over 1 year. Secondary outcomes included asthma control test and St George's Respiratory Questionnaire scores, fractional exhaled nitric oxide and concentrations of inflammatory markers in induced sputum. Subgroup analyses were performed to determine whether effects of supplementation were modified by baseline vitamin D status or genotype for 34 single nucleotide polymorphisms in 11 vitamin D pathway genes.

MAIN RESULTS

206/250 participants (82%) were vitamin D insufficient at baseline. Vitamin D3 did not influence time to first severe exacerbation (adjusted HR 1.02, 95% CI 0.69 to 1.53, p=0.91) or first URI (adjusted HR 0.87, 95% CI 0.64 to 1.16, p=0.34). No clinically important effect of vitamin D3 was seen on any of the secondary outcomes listed above. The influence of vitamin D3 on coprimary outcomes was not modified by baseline vitamin D status or genotype.

CONCLUSIONS

Bolus-dose vitamin D3 supplementation did not influence time to exacerbation or URI in a population of adults with asthma with a high prevalence of baseline vitamin D insufficiency.

TRIAL REGISTRATION NUMBER

NCT00978315 (ClinicalTrials.gov).

Authors+Show Affiliations

Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK Asthma UK Centre for Applied Research, Blizard Institute, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK Asthma UK Centre for Applied Research, Blizard Institute, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.Homerton University Hospital, London, UK.Homerton University Hospital, London, UK.Homerton University Hospital, London, UK.Homerton University Hospital, London, UK.Homerton University Hospital, London, UK.Queen's Hospital, Rom Valley Way, Romford, London, UK.Royal London Hospital, London, UK.London School of Hygiene and Tropical Medicine, London, UK.NIHR Leicester Respiratory Biomedical Research Unit, Glenfield Hospital, Leicester, UK.MRC and the Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, London, UK.MRC and the Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, London, UK.Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK Asthma UK Centre for Applied Research, Blizard Institute, Queen Mary University of London, London, UK MRC and the Asthma UK Centre for Allergic Mechanisms in Asthma, King's College London, London, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25724847

Citation

Martineau, Adrian R., et al. "Double-blind Randomised Placebo-controlled Trial of Bolus-dose Vitamin D3 Supplementation in Adults With Asthma (ViDiAs)." Thorax, vol. 70, no. 5, 2015, pp. 451-7.
Martineau AR, MacLaughlin BD, Hooper RL, et al. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015;70(5):451-7.
Martineau, A. R., MacLaughlin, B. D., Hooper, R. L., Barnes, N. C., Jolliffe, D. A., Greiller, C. L., ... Griffiths, C. J. (2015). Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax, 70(5), pp. 451-7. doi:10.1136/thoraxjnl-2014-206449.
Martineau AR, et al. Double-blind Randomised Placebo-controlled Trial of Bolus-dose Vitamin D3 Supplementation in Adults With Asthma (ViDiAs). Thorax. 2015;70(5):451-7. PubMed PMID: 25724847.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). AU - Martineau,Adrian R, AU - MacLaughlin,Beverley D, AU - Hooper,Richard L, AU - Barnes,Neil C, AU - Jolliffe,David A, AU - Greiller,Claire L, AU - Kilpin,Kate, AU - McLaughlin,David, AU - Fletcher,Gareth, AU - Mein,Charles A, AU - Hoti,Mimoza, AU - Walton,Robert, AU - Grigg,Jonathan, AU - Timms,Peter M, AU - Rajakulasingam,Raj K, AU - Bhowmik,Angshu, AU - Rowe,Marion, AU - Venton,Timothy R, AU - Choudhury,Aklak B, AU - Simcock,David E, AU - Sadique,Zia, AU - Monteiro,William R, AU - Corrigan,Christopher J, AU - Hawrylowicz,Catherine M, AU - Griffiths,Christopher J, Y1 - 2015/02/27/ PY - 2014/10/15/received PY - 2015/01/27/accepted PY - 2015/3/1/entrez PY - 2015/3/1/pubmed PY - 2015/6/24/medline KW - Asthma KW - Respiratory Infection KW - Viral infection SP - 451 EP - 7 JF - Thorax JO - Thorax VL - 70 IS - 5 N2 - RATIONALE: Asthma exacerbations are commonly precipitated by viral upper respiratory infections (URIs). Vitamin D insufficiency associates with susceptibility to URI in patients with asthma. Trials of vitamin D in adults with asthma with incidence of exacerbation and URI as primary outcome are lacking. OBJECTIVE: To conduct a randomised controlled trial of vitamin D3 supplementation for the prevention of asthma exacerbation and URI (coprimary outcomes). MEASUREMENTS AND METHODS: 250 adults with asthma in London, UK were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 (n=125) or placebo (n=125) over 1 year. Secondary outcomes included asthma control test and St George's Respiratory Questionnaire scores, fractional exhaled nitric oxide and concentrations of inflammatory markers in induced sputum. Subgroup analyses were performed to determine whether effects of supplementation were modified by baseline vitamin D status or genotype for 34 single nucleotide polymorphisms in 11 vitamin D pathway genes. MAIN RESULTS: 206/250 participants (82%) were vitamin D insufficient at baseline. Vitamin D3 did not influence time to first severe exacerbation (adjusted HR 1.02, 95% CI 0.69 to 1.53, p=0.91) or first URI (adjusted HR 0.87, 95% CI 0.64 to 1.16, p=0.34). No clinically important effect of vitamin D3 was seen on any of the secondary outcomes listed above. The influence of vitamin D3 on coprimary outcomes was not modified by baseline vitamin D status or genotype. CONCLUSIONS: Bolus-dose vitamin D3 supplementation did not influence time to exacerbation or URI in a population of adults with asthma with a high prevalence of baseline vitamin D insufficiency. TRIAL REGISTRATION NUMBER: NCT00978315 (ClinicalTrials.gov). SN - 1468-3296 UR - https://www.unboundmedicine.com/medline/citation/25724847/Double_blind_randomised_placebo_controlled_trial_of_bolus_dose_vitamin_D3_supplementation_in_adults_with_asthma__ViDiAs__ L2 - http://thorax.bmj.com/cgi/pmidlookup?view=long&pmid=25724847 DB - PRIME DP - Unbound Medicine ER -