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Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial.

Abstract

BACKGROUND

Patients with chronic obstructive pulmonary disease (COPD) often have vitamin D deficiency, which is associated with increased susceptibility to upper respiratory infection-a major precipitant of exacerbation. Multicentre trials of vitamin D supplementation for prevention of exacerbation and upper respiratory infection in patients with COPD are lacking. We therefore investigated whether vitamin D3 (colecalciferol) supplementation would reduce the incidence of moderate or severe COPD exacerbations and upper respiratory infections.

METHODS

We did a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation in adults with COPD in 60 general practices and four Acute National Health Service Trust clinics in London, UK. Patients were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 or placebo over 1 year in a 1:1 ratio using computer-generated permuted block randomisation. Participants and study staff were masked to treatment assignment. Coprimary outcomes were time to first moderate or severe exacerbation and first upper respiratory infection. Analysis was by intention to treat. A prespecified subgroup analysis was done to assess whether effects of the intervention on the coprimary outcomes were modified by baseline vitamin D status. This trial is registered with ClinicalTrials.gov, number NCT00977873.

FINDINGS

240 patients were randomly allocated to the vitamin D3 group (n=122) and placebo group (n=118). Vitamin D3 compared with placebo did not affect time to first moderate or severe exacerbation (adjusted hazard ratio 0·86, 95% CI 0·60-1·24, p=0·42) or time to first upper respiratory infection (0·95, 0·69-1·31, p=0·75). Prespecified subgroup analysis showed that vitamin D3 was protective against moderate or severe exacerbation in participants with baseline serum 25-hydroxyvitamin D concentrations of less than 50 nmol/L (0·57, 0·35-0·92, p=0·021), but not in those with baseline 25-hydroxyvitamin D levels of at least 50 nmol/L (1·45, 0·81-2·62, p=0·21; p=0·021 for interaction between allocation and baseline serum 25-hydroxyvitamin D status). Baseline vitamin D status did not modify the effect of the intervention on risk of upper respiratory infection (pinteraction=0·41).

INTERPRETATION

Vitamin D3 supplementation protected against moderate or severe exacerbation, but not upper respiratory infection, in patients with COPD with baseline 25-hydroxyvitamin D levels of less than 50 nmol/L. Our findings suggest that correction of vitamin D deficiency in patients with COPD reduces the risk of moderate or severe exacerbation.

FUNDING

UK National Institute for Health Research.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

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    Barts and 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. Electronic address: a.martineau@qmul.ac.uk.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Barts and 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.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Barts and London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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    Homerton University Hospital, Homerton Row, London, UK.

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    Homerton University Hospital, Homerton Row, London, UK.

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    Homerton University Hospital, Homerton Row, London, UK.

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    Homerton University Hospital, Homerton Row, London, UK.

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    Homerton University Hospital, Homerton Row, London, UK.

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    Queen's Hospital, Rom Valley Way, Romford, UK.

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    Royal London Hospital, Whitechapel Road, London, UK.

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    Royal London Hospital, Whitechapel Road, London, UK.

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    Royal London Hospital, Whitechapel Road, London, UK.

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    London School of Hygiene & Tropical Medicine, London, UK.

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    Leicester Respiratory Biomedical Research Unit, Glenfield Hospital, Groby Road, Leicester, UK.

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    Medical Research Council, Asthma UK Centre in Allergic Mechanisms in Asthma, King's College London, London, UK.

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    Medical Research Council, Asthma UK Centre in Allergic Mechanisms in Asthma, King's College London, London, UK.

    Barts and 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; Medical Research Council, Asthma UK Centre in Allergic Mechanisms in Asthma, King's College London, London, UK.

    Source

    The Lancet. Respiratory medicine 3:2 2015 Feb pg 120-130

    MeSH

    Aged
    Cholecalciferol
    Dietary Supplements
    Double-Blind Method
    Female
    Humans
    Male
    Middle Aged
    Pulmonary Disease, Chronic Obstructive
    Respiratory Tract Infections
    Vitamin D
    Vitamin D Deficiency
    Vitamins

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    25476069

    Citation

    Martineau, Adrian R., et al. "Vitamin D3 Supplementation in Patients With Chronic Obstructive Pulmonary Disease (ViDiCO): a Multicentre, Double-blind, Randomised Controlled Trial." The Lancet. Respiratory Medicine, vol. 3, no. 2, 2015, pp. 120-130.
    Martineau AR, James WY, Hooper RL, et al. Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2015;3(2):120-130.
    Martineau, A. R., James, W. Y., Hooper, R. L., Barnes, N. C., Jolliffe, D. A., Greiller, C. L., ... Griffiths, C. J. (2015). Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. The Lancet. Respiratory Medicine, 3(2), pp. 120-130. doi:10.1016/S2213-2600(14)70255-3.
    Martineau AR, et al. Vitamin D3 Supplementation in Patients With Chronic Obstructive Pulmonary Disease (ViDiCO): a Multicentre, Double-blind, Randomised Controlled Trial. Lancet Respir Med. 2015;3(2):120-130. PubMed PMID: 25476069.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Vitamin D3 supplementation in patients with chronic obstructive pulmonary disease (ViDiCO): a multicentre, double-blind, randomised controlled trial. AU - Martineau,Adrian R, AU - James,Wai Yee, AU - Hooper,Richard L, AU - Barnes,Neil C, AU - Jolliffe,David A, AU - Greiller,Claire L, AU - Islam,Kamrul, AU - McLaughlin,David, AU - Bhowmik,Angshu, AU - Timms,Peter M, AU - Rajakulasingam,Raj K, AU - Rowe,Marion, AU - Venton,Timothy R, AU - Choudhury,Aklak B, AU - Simcock,David E, AU - Wilks,Mark, AU - Degun,Amarjeet, AU - Sadique,Zia, AU - Monteiro,William R, AU - Corrigan,Christopher J, AU - Hawrylowicz,Catherine M, AU - Griffiths,Christopher J, Y1 - 2014/12/02/ PY - 2014/12/6/entrez PY - 2014/12/6/pubmed PY - 2016/2/5/medline SP - 120 EP - 130 JF - The Lancet. Respiratory medicine JO - Lancet Respir Med VL - 3 IS - 2 N2 - BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) often have vitamin D deficiency, which is associated with increased susceptibility to upper respiratory infection-a major precipitant of exacerbation. Multicentre trials of vitamin D supplementation for prevention of exacerbation and upper respiratory infection in patients with COPD are lacking. We therefore investigated whether vitamin D3 (colecalciferol) supplementation would reduce the incidence of moderate or severe COPD exacerbations and upper respiratory infections. METHODS: We did a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation in adults with COPD in 60 general practices and four Acute National Health Service Trust clinics in London, UK. Patients were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 or placebo over 1 year in a 1:1 ratio using computer-generated permuted block randomisation. Participants and study staff were masked to treatment assignment. Coprimary outcomes were time to first moderate or severe exacerbation and first upper respiratory infection. Analysis was by intention to treat. A prespecified subgroup analysis was done to assess whether effects of the intervention on the coprimary outcomes were modified by baseline vitamin D status. This trial is registered with ClinicalTrials.gov, number NCT00977873. FINDINGS: 240 patients were randomly allocated to the vitamin D3 group (n=122) and placebo group (n=118). Vitamin D3 compared with placebo did not affect time to first moderate or severe exacerbation (adjusted hazard ratio 0·86, 95% CI 0·60-1·24, p=0·42) or time to first upper respiratory infection (0·95, 0·69-1·31, p=0·75). Prespecified subgroup analysis showed that vitamin D3 was protective against moderate or severe exacerbation in participants with baseline serum 25-hydroxyvitamin D concentrations of less than 50 nmol/L (0·57, 0·35-0·92, p=0·021), but not in those with baseline 25-hydroxyvitamin D levels of at least 50 nmol/L (1·45, 0·81-2·62, p=0·21; p=0·021 for interaction between allocation and baseline serum 25-hydroxyvitamin D status). Baseline vitamin D status did not modify the effect of the intervention on risk of upper respiratory infection (pinteraction=0·41). INTERPRETATION: Vitamin D3 supplementation protected against moderate or severe exacerbation, but not upper respiratory infection, in patients with COPD with baseline 25-hydroxyvitamin D levels of less than 50 nmol/L. Our findings suggest that correction of vitamin D deficiency in patients with COPD reduces the risk of moderate or severe exacerbation. FUNDING: UK National Institute for Health Research. SN - 2213-2619 UR - https://www.unboundmedicine.com/medline/citation/25476069/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S2213-2600(14)70255-3 DB - PRIME DP - Unbound Medicine ER -