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

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ClinicalTrials.gov Identifier: NCT01069874
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Vigantol oil


Outcome Measures
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Primary Outcome Measures :
  1. Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff [ Time Frame: One year ]
  2. Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff [ Time Frame: One year ]
  3. Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff [ Time Frame: One year ]
  4. Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069874


Locations
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United Kingdom
Hanover in Hackney Housing Association
London, United Kingdom
Sanctuary Group Housing Association
London, United Kingdom
Sponsors and Collaborators
Barts & The London NHS Trust
National Health Service, United Kingdom
Investigators
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Study Director: Adrian R Martineau, MRCP Queen Mary University of London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01069874    
Other Study ID Numbers: 2009-010085-35
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Barts & The London NHS Trust:
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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents