Clinical trial NCT01069874: Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Respiratory Tract Infections
Influenza
Keywords: Bone Density Conservation Agents
Cholecalciferol
Communicable Diseases
Growth Substances
Housing for the Elderly
Infection
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory Tract Diseases
Vitamins
Respiratory Tract Infections/prevention & control*
Vitamin D
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2010-02-17
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
timeFrame: One year
Secondary outcomes:
measure: Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
timeFrame: One year
measure: Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
timeFrame: One year
measure: Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
timeFrame: One year
measure: Proportion of participants experiencing hypercalcaemia
timeFrame: One year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hanover in Hackney Housing Association
city: London
country: United Kingdom
facility: Sanctuary Group Housing Association
Study officials:
affiliation: Queen Mary University of London
name: Adrian R Martineau, MRCP
role: STUDY_DIRECTOR
References:
citation: Martineau AR, Hanifa Y, Witt KD, Barnes NC, Hooper RL, Patel M, Stevens N, Enayat Z, Balayah Z, Syed A, Knight A, Jolliffe DA, Greiller CL, McLaughlin D, Venton TR, Rowe M, Timms PM, Clark D, Sadique Z, Eldridge SM, Griffiths CJ. Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu). Thorax. 2015 Oct;70(10):953-60. doi: 10.1136/thoraxjnl-2015-206996. Epub 2015 Jun 10.