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

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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Miglyol oil
  • Miglyol oil will be administered in 2-monthly oral bolus doses 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

Primary Measures

• Time to first respiratory tract infection (upper or lower) in sheltered accommodation residents
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• Time to first respiratory tract infection (upper or lower) in sheltered accommodation staff
  • Time Frame: One year
    Safety Issue?: No
• Annual rate of episodes of upper / lower respiratory infection in sheltered accommodation residents / staff
  • Time Frame: One year
    Safety Issue?: No
• Time to unscheduled health service use for respiratory tract infection in sheltered accommodation residents / staff
  • Time Frame: One year
    Safety Issue?: No
• Proportion of participants experiencing hypercalcaemia
  • Time Frame: One year
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Barts & The London NHS Trust Other

Overall Clinical Trial Officials and Contacts

Adrian R Martineau, MRCP Study Director Queen Mary University of London  

Overall Contact: Adrian R Martineau, MRCP +442078822551 a.martineau@qmul.ac.uk

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01069874

Study ID Number: 2009-010085-35

ClinicalTrials.gov Identifier: NCT01069874

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency