A single dose of vitamin D every two months could cut the number of people with asthma, COPD, or living in nursing homes who end up needing emergency care for a respiratory infection. Respiratory infections are a major burden on the NHS, and people with chronic lung conditions or in care settings are especially vulnerable. In the UK, winter sunlight is too weak for the skin to make vitamin D, leaving many adults deficient. This project tests whether giving a high-dose vitamin D supplement every two months can prevent these infections and reduce hospital visits. If the trials show it works, the NHS could adopt a simple, low-cost supplement strategy for millions of at-risk people. That would mean fewer GP appointments, fewer hospital admissions, and fewer days off work. The research also includes an economic model to confirm whether the approach saves the health service money. Because the at-risk groups are large and vitamin D deficiency is widespread, even a modest effect could have a huge impact on public health.
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AIMTo determine whether high-dose bolus vitamin D supplementation is a cost-effective and acceptable strategy to reduce unscheduled care for acute respiratory illness.OBJECTIVES1) To perform cross-sectional studies of prevalence and determinants of vitamin D insufficiency in 4 populations at high risk of acute respiratory illness.2) To conduct randomised controlled trials to determine whether high-dose bolus vitamin D supplementation reduces acute respiratory illness in these populations.3) To define acceptable policy for prevention and treatment of vitamin D insufficiency using qualitative work4) To conduct a meta-analysis and economic modelling of cost-effectiveness and cost-utility of vitamin D supplementation in the NHS.BACKGROUNDRespiratory infections cause 20% of GP consultations, 300,000 hospital admissions and 30,000 deaths/year. Patients with asthma or chronic obstructive pulmonary disease (COPD), and nursing home residents and staff are at high risk. This programme will determine whether high-dose bolus vitamin D supplementation cost-effectively prevents respiratory infections in these groups.Vitamin D is made when sunlight strikes the skin. In the UK, winter and spring sunshine is too weak to induce skin synthesis, and 87% of adults develop moderate vitamin D deficiency, termed ‘insufficiency', and defined as serum 25-hydroxyvitaminD (25(OH)D) RESEARCH PLANS• Phase 1We will conduct cross-sectional studies to determine the prevalence and determinants of vitamin D insufficiency in 360 patients with asthma, 360 patients with COPD, 1000 nursing home residents and 1000 nursing home staff.• Phase 2We will conduct 2 double-blind placebo-controlled RCTs in these populations powered to determine whether a 2-monthly supervised oral dose of 120,000 IU vitamin D reduces acute respiratory illness requiring unscheduled health care use. Patients with asthma or COPD will be individually randomised to vitamin D or placebo; nursing home residents and staff will be cluster-randomised at nursing home level to detect potential herd effects. Participants will be followed up at 2-monthly intervals for one year. • Phase 3We will conduct a qualitative study in 100 participants to determine acceptability of different strategies to correct vitamin D insufficiency.• Phase 4We will conduct a meta-analysis to determine the size of treatment effect in different sub-groups, and construct an economic model to determine cost-effectiveness and cost-utility of vitamin D supplementation for the NHS.RESEARCH TEAMOur team combines leading researchers on vitamin D with highly experienced community trialists, clinicians, a social scientist, a statistician, a health economist and a lay advisor.RESEARCH ENVIRONMENTThe academic environment formed by the collaboration between Barts and the London, Queen Mary University and the MRC Asthma UK Centre in Allergic Mechanisms of Asthma brings an unrivalled multidisciplinary team with all the required expertise to bring this programme to a successful conclusion. OUTPUTS, OUTCOMES AND IMPACTSOutputs include new knowledge on prevalence and determinants of vitamin D insufficiency; effectiveness of vitamin D supplementation for the prevention of respiratory illness; consumer acceptability of correction strategies; and cost-effectiveness of vitamin D supplementation to reduce respiratory illness.Anticipated outcomes include reductions in health care use, incidence of respiratory illness, health service costs and days off work.Because at-risk groups are so large, and vitamin D insufficiency is so prevalent, the impact of positive findings from our programme would be huge. PUBLIC INVOLVEMENTA lay advisor and a Patient Research Advisory Group have contributed significantly to design of this programme. Their continued input will ensure that we remain focussed on outcomes of priority to NHS users.ETHICAL IMPLICATIONSVitamin D supplementation is safe; participants will receive more intensive follow-up than usual care. Benefits
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