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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069874

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

ClinicalTrials.gov processed this record on November 20, 2014