Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01069874

Collaborator

National Health Service, United Kingdom (Other)

240

Enrollment

Locations

Arms

Duration (Months)

120

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tract Infections Influenza	Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil) Dietary Supplement: Miglyol oil	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Miglyol oil Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year	Dietary Supplement: Miglyol oil Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year
Active Comparator: Vigantol oil Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year	Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil) Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year Other Names: Vigantol oil

Arm

Intervention/Treatment

Placebo Comparator: Miglyol oil

Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Miglyol oil

Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year

Active Comparator: Vigantol oil

Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year

Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil)

Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year

Other Names:

Vigantol oil

Outcome Measures

Primary Outcome Measures

Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents [One year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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