Influenza Clinical Trial
— ViDiFluOfficial 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)
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
Status | Completed |
Enrollment | 240 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Permanent resident or member of staff at sheltered accommodation unit - If a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study - Able to give written informed consent to participate - Age = 16 years on day of first dose of IMP Exclusion Criteria: - Current diagnosis of asthma or chronic obstructive pulmonary disease - Chronic upper or lower respiratory infection or other condition causing chronic cough - Condition requiring treatment with vitamin D at a dose of > 10 micrograms vitamin D/day - Episode of upper or lower respiratory tract infection up to 28 days before first dose of IMP - Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment - Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy - Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP - Using topical vitamin D analogue - Treatment with any investigational medical product or device up to 4 months before first dose of IMP - Breastfeeding, pregnant or planning a pregnancy - Baseline corrected serum calcium > 2.65 mmol/L - Baseline serum creatinine > 125 micromol/L - Inability to complete symptom diary with / without assistance - Cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hanover in Hackney Housing Association | London | |
United Kingdom | Sanctuary Group Housing Association | London |
Lead Sponsor | Collaborator |
---|---|
Barts & The London NHS Trust | National Health Service, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents | One year | No | |
Secondary | Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff | One year | No | |
Secondary | Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff | One year | No | |
Secondary | Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff | One year | No | |
Secondary | Proportion of participants experiencing hypercalcaemia | One year | Yes |
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