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

Primary Purpose

Respiratory Tract Infections, Influenza

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Cholecalciferol (Vitamin D/Vigantol oil)
Miglyol oil
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hanover in Hackney Housing Association
  • Sanctuary Group Housing Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Miglyol oil

Vigantol oil

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents

Secondary Outcome Measures

Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
Proportion of participants experiencing hypercalcaemia

Full Information

First Posted
February 16, 2010
Last Updated
February 3, 2014
Sponsor
Barts & The London NHS Trust
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01069874
Brief Title
Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections (ViDiFlu)
Acronym
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
National Health Service, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miglyol oil
Arm Type
Placebo Comparator
Arm Description
Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year
Arm Title
Vigantol oil
Arm Type
Active Comparator
Arm Description
Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol (Vitamin D/Vigantol oil)
Other Intervention Name(s)
Vigantol oil
Intervention Description
Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Miglyol oil
Intervention Description
Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year
Primary Outcome Measure Information:
Title
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
Time Frame
One year
Secondary Outcome Measure Information:
Title
Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
Time Frame
One year
Title
Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
Time Frame
One year
Title
Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
Time Frame
One year
Title
Proportion of participants experiencing hypercalcaemia
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian R Martineau, MRCP
Organizational Affiliation
Queen Mary University of London
Official's Role
Study Director
Facility Information:
Facility Name
Hanover in Hackney Housing Association
City
London
Country
United Kingdom
Facility Name
Sanctuary Group Housing Association
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26063508
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.
Results Reference
derived

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

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