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S104 Double-blind Multi-centre Randomised Controlled Trial Of Vitamin D3 Supplementation In Copd (vidico)
  1. AR Martineau1,
  2. WY James1,
  3. RL Hooper1,
  4. NC Barnes1,
  5. DA Jolliffe1,
  6. A Bhowmik2,
  7. RK Rajakulasingam1,
  8. AB Choudhury3,
  9. DE Simcock4,
  10. CJ Corrigan5,
  11. CM Hawrylowicz5,
  12. CJ Griffiths1
  1. 1Queen Mary University of London, London, UK
  2. 2Homerton Hospital, London, UK
  3. 3Queen’s Hospital, Romford, UK
  4. 4Royal London Hospital, London, UK
  5. 5King’s College London, London, UK

Abstract

Introduction and objectives Inadequate vitamin D status is common in patients with COPD, and it associates with susceptibility to upper respiratory infection (URI) – a major precipitant of exacerbation. Multi-centre trials of vitamin D supplementation for prevention of exacerbation and URI in COPD are lacking. We therefore conducted a multi-centre double-blind randomised placebo-controlled trial of vitamin D supplementation for the prevention of moderate/severe exacerbation and URI in adults with COPD.

Methods Two hundred and forty patients were allocated to receive a 2-monthly oral dose of 3 mg vitamin D3 or placebo for one year. Co-primary outcomes were time to first moderate/severe exacerbation and time to first URI. Secondary outcomes included peak severity and area under the curve for exacerbation symptoms. A pre-specified sub-group analysis was conducted to determine whether effects of the intervention on co-primary outcomes were modified by baseline vitamin D status. This trial is registered with ClinicalTrials.gov (NCT00977873).

Results 122 participants were allocated to the intervention arm of the trial, and 118 to the control arm. Vitamin D supplementation did not influence time to first exacerbation (HR 0.86, 95% CI 0.60–1.24, p = 0.42) or time to first URI (HR 0.95, 95% CI 0.69–1.31, p = 0.75) in the study population as a whole, but it did reduce peak severity (p = 0.042) and area under the curve (p = 0.032) for exacerbation symptoms. Pre-specified sub-group analysis revealed that vitamin D supplementation was protective against moderate/severe exacerbation among the 148 participants with baseline serum 25-hydroxyvitamin D (25[OH]D) concentration < 50 nmol/L (aHR 0.57, 95% CI 0.35 to 0.92, p = 0.021), but not among the 92 participants with baseline serum 25(OH)D ≥ 50 nmol/L (aHR 1.45, 95% CI 0.81 to 2.62, p = 0.21; P for interaction = 0.021). Baseline vitamin D status did not modify the effect of vitamin D supplementation on risk of URI (P for interaction = 0.41).

Conclusions Vitamin D supplementation protected against moderate/severe exacerbation, but not upper respiratory infection, in COPD patients with baseline 25(OH)D < 50 nmol/L. It also modestly reduced peak severity and area under the curve for exacerbation symptom scores, irrespective of baseline vitamin D status.

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