Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
Phase 2
Completed
- Conditions
- Respiratory Tract InfectionsInfluenza
- Interventions
- Dietary Supplement: Miglyol oilDietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil)
- Registration Number
- NCT01069874
- Lead Sponsor
- Barts & The London NHS Trust
- Brief Summary
Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.
- Detailed Description
The study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. Half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin D supplementation (Vigantol oil) over a period of one year, and half to placebo.
Participants will be followed for one year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Miglyol oil Miglyol oil Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year Vigantol oil Cholecalciferol (Vitamin D/Vigantol oil) Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
- Primary Outcome Measures
Name Time Method Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents One year
- Secondary Outcome Measures
Name Time Method Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff One year Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff One year Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff One year Proportion of participants experiencing hypercalcaemia One year
Trial Locations
- Locations (2)
Sanctuary Group Housing Association
🇬🇧London, United Kingdom
Hanover in Hackney Housing Association
🇬🇧London, United Kingdom