Trial of vitamin D supplementation in asthma

• Research type

  Research Study

• Full title

  RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF VITAMIN D SUPPLEMENTATION IN ADULT AND ADOLESCENT PATIENTS WITH ASTHMA

• IRAS ID

  16543

• Contact name

  Adrian Martineau

• Sponsor organisation

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

• Eudract number

  2009-010083-42

• 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 respiratory infection. Respiratory infections cause 20% of GP consultations, 300,000 hospital admissions and 30,000 deaths per year. Patients with asthma 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 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 asthma.This trial will recruit 250 patients aged twelve to eighty years, with a physician diagnosis of asthma, who fulfil protocol-specified eligibility criteria.The study will be conducted in primary and secondary care sites within inner London. 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 asthma symptoms, and to blood samples and perform breathing tests at the beginning, the middle and the end of the study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/67

• Date of REC Opinion

  29 Jun 2009

• REC opinion

  Further Information Favourable Opinion