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

Influenza Clinical Trial

— ViDiFlu  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069874
• Other study ID #: 2009-010085-35
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 16, 2010
• Last updated: February 3, 2014
• Start date: March 2010
• Est. completion date: April 2013

Study information

• Verified date: February 2014
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections

Intervention

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
• Miglyol oil
Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year

Locations

Country	Name	City	State
United Kingdom	Hanover in Hackney Housing Association	London
United Kingdom	Sanctuary Group Housing Association	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents		One year	No
Secondary	Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff		One year	No
Secondary	Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff		One year	No
Secondary	Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff		One year	No
Secondary	Proportion of participants experiencing hypercalcaemia		One year	Yes