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

February 3, 2014 updated by: Barts & The London NHS Trust

Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and Other Respiratory Infections in Sheltered Accommodation (ViDiFlu)

Purpose: The study null hypothesis is that vitamin D supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Hanover in Hackney Housing Association
      • London, United Kingdom
        • Sanctuary Group Housing Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
Time Frame: One year
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

National Health Service, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-010085-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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