Trial of Vitamin D Supplementation in Asthma

Study Overview
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Brief Summary
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The study null hypothesis is that vitamin D supplementation will not influence time to upper respiratory tract infection or time to severe asthma exacerbation in adult and adolescent patients with asthma.

Official Title
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Randomised, Multi-centre, Double-blind, Placebo-controlled Trial of Vitamin D Supplementation in Adult and Adolescent Patients With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Miglyol oil


Participation Criteria
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Eligibility Criteria
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Principal Inclusion Criteria: Medical record diagnosis of asthma Age ≥ 16 years and ≤ 80 years on day of first dose of IMP 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 in the study Principal Exclusion Criteria: Diagnosis of COPD Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for ≥ 3 years Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone Taking dietary supplement containing vitamin D 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 Smoking history >15 pack-years

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vigantol oil<br>Vigantol oil will be administered in 2-monthly oral bolus doses over a period of one year | Dietary Supplement: Cholecalciferol<br>* Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year<br>|
| Placebo Comparator: Miglyol oil<br>Miglyol oil will be administered in 2-monthly oral bolus doses over a period of one year | Dietary Supplement: Miglyol oil<br>* Miglyol oil will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first upper respiratory tract infection |  | One year | 
| Time to first severe asthma exacerbation |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test Score |  | One year | 
| Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation |  | One year | 
| Proportion of participants experiencing hypercalcaemia |  | One year |