Trial of vitamin D supplementation for prevention of influenza

• Research type

  Research Study

• Full title

  Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and other Respiratory Infections in Sheltered Accommodation (ViDiFlu)

• IRAS ID

  20593

• Contact name

  Adrian Martineau

• Sponsor organisation

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

• Eudract number

  2009-010085-35

• 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. Sheltered accommodation residents and staff 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 prevent flunza and other respiratory infections in sheltered accommodation residents and staff.This trial will recruit residents and staff in 36 residential accommodation units who fulfil protocol-specified eligibility criteria.The study will be conducted in sheltered accommodation units in London. Participant involvement will be for 1 year, during which time they will meet with study staff on 10 occasions. Participants will be asked to complete a daily diary of respiratory symptoms, and to give blood samples at the beginning, middle and end of the study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/112

• Date of REC Opinion

  14 Jan 2010

• REC opinion

  Further Information Favourable Opinion