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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2009-010085-35-GB |
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Date of registration:
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14/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and other Respiratory Infections in Sheltered Accommodation (ViDiFlu) - Trial of vitamin D supplementation for prevention of influenza
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Scientific title:
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Cluster-randomised, Double-Blind, Placebo-Controlled Trial of Vitamin D Supplementation for the Prevention of Influenza and other Respiratory Infections in Sheltered Accommodation (ViDiFlu) - Trial of vitamin D supplementation for prevention of influenza |
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Date of first enrolment:
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14/01/2010 |
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Target sample size:
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240 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010085-35 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Permanent resident or member of staff at sheltered accommodation unit • Able to meet with study staff at 2-monthly intervals for the duration of participation in the study • 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria:
• Current diagnosis of asthma or COPD • 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 occurring 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 • 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 or without assistance • Severe cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations • Any other condition that, in an investigator’s judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Trial in healthy volunteers; intended indication is for prevention of respiratory tract infections
MedDRA version: 14.1
Level: PT
Classification code 10062352
Term: Respiratory tract infection
System Organ Class: 10021881 - Infections and infestations
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Intervention(s)
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Trade Name: Vigantol Oil
Product Name: Vigantol Oil
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Trade Name: Vigantol Oil
Product Name: Vigantol Oil
Pharmaceutical Form: Oral solution
Pharmaceutical form of the placebo: Oral liquid
Route of administration of the placebo: Oral use
Trade Name: Vigantol Oil
Product Name: Vigantol Oil
Pharmaceutical Form: Oral solution
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Primary Outcome(s)
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Secondary Objective: 1. Does high-dose vitamin D supplementation reduce health service use in sheltered accomodation residents and staff? 2. Does high-dose vitamin D supplementation improve quality of life in sheltered accomodation residents and staff? 3. Does high-dose vitamin D supplementation reduce illness-related costs and days of absence from work in sheltered accomodation staff?
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Main Objective: Does high-dose vitamin D supplementation prevent influenza and other respiratory infections in sheltered accomodation residents and staff?
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Primary end point(s): The primary outcome measure for this trial is time from randomisation to first respiratory tract infection in sheltered accommodation residents
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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