Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
ViDiFlu
Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu)
1 other identifier
interventional
240
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2010
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFebruary 4, 2014
February 1, 2014
3.1 years
February 16, 2010
February 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
One year
Secondary Outcomes (4)
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
Study Arms (2)
Miglyol oil
PLACEBO COMPARATORMiglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Vigantol oil
ACTIVE COMPARATORVigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Interventions
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hanover in Hackney Housing Association
London, United Kingdom
Sanctuary Group Housing Association
London, United Kingdom
Related Publications (1)
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.
PMID: 26063508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adrian R Martineau, MRCP
Queen Mary University of London
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
March 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-02