Trial in healthy volunteers
Conditions
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Permanent resident or member of staff at sheltered accommodation unit • Able to meet with study staff at 2-monthly intervals for the duration of participation in the study • 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 Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Current diagnosis of asthma or COPD • 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 occurring 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 • 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 or without assistance • Severe cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations • Any other condition that, in an investigator’s judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does high-dose vitamin D supplementation prevent influenza and other respiratory infections in sheltered accomodation residents and staff?;Primary end point(s): The primary outcome measure for this trial is time from randomisation to first respiratory tract infection in sheltered accommodation residents;Secondary Objective: 1. Does high-dose vitamin D supplementation reduce health service use in sheltered accomodation residents and staff? 2. Does high-dose vitamin D supplementation improve quality of life in sheltered accomodation residents and staff? 3. Does high-dose vitamin D supplementation reduce illness-related costs and days of absence from work in sheltered accomodation staff? | — |
Countries
United Kingdom
Outcome results
None listed