Trial of vitamin D supplementation in COPD

• Research type

  Research Study

• Full title

  Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation in Patients with Chronic Obstructive Pulmonary Disease

• IRAS ID

  18976

• Sponsor organisation

  Barts and The London, Queen Mary's School of Medicine and Dentistry

• Eudract number

  2009-010084-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Vitamin D - the sunshine vitamin - is best known for its effects on bone health: profound deficiency causes rickets. More moderate deficiency, commonly seen in the UK during winter and spring, is associated with susceptibility to respiratoryinfection. Respiratory infections cause 20% of GP consultations, 300,000 hospital admissions and 30,000 deaths per year. Patients with COPD are at high risk.Our laboratory studies show that vitamin D Ó?switches on? the production of natural antibiotic substances that can kill viruses and bacteria in cells that fight infection. One small trial, originally designed to look at the effects of vitamin D on bone health has shown that patients receiving high-dose vitamin D were 3 times less likely to have cold and flusymptoms than those who received placebo.AIMThe primary aim of the study is to determine whether vitamin D supplementation is a cost-effective and acceptable strategy to reduce acute respiratory illness in patients with COPD.This trial will recruit 240 patients aged 40 years and over, with a physician diagnosis of COPD, who fulfil protocol-specified eligibility criteria.The study will be conducted in primary and secondary care sites in London and Norfolk. Participant involvement will be for 1 year, throughout which time they will attend for five study visits and be contacted by telephone on five occasions at intervals between scheduled visits. Participants will be asked to complete a daily diary of chest symptoms, and give blood samples and perform breathing tests and tests of muscle strength at the beginning, the middle and the end of the study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/76

• Date of REC Opinion

  24 Jul 2009

• REC opinion

  Further Information Favourable Opinion