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

Barts & The London NHS Trust

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza; Respiratory Tract Infections

Treatments: Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil); Dietary Supplement: Miglyol oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01069874

2009-010085-35

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

Miglyol oil

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Miglyol oil

Vigantol oil

Active Comparator group

Description:

Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year

Treatment:

Dietary Supplement: Cholecalciferol (Vitamin D/Vigantol oil)