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

This study has been completed.
Sponsor:
Collaborator:
National Health Service, United Kingdom
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01069874
First received: February 16, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Proportion of participants experiencing hypercalcaemia [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Miglyol oil
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069874

Locations
United Kingdom
Sanctuary Group Housing Association
London, United Kingdom
Hanover in Hackney Housing Association
London, United Kingdom
Sponsors and Collaborators
Barts & The London NHS Trust
National Health Service, United Kingdom
Investigators
Study Director: Adrian R Martineau, MRCP Queen Mary University of London
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01069874     History of Changes
Other Study ID Numbers: 2009-010085-35
Study First Received: February 16, 2010
Last Updated: February 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014