Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7530
Study information
Scientific title
Randomised, multi-centre, double-blind, placebo-controlled prevention trial of vitamin D supplementation in adult and adolescent patients with asthma
Acronym
Trial of vitamin D supplementation in asthma
Study hypothesis
Asthma is a common chronic inflammatory condition of the airways. Exacerbations of asthma cause significant morbidity and health care use in the UK. They are commonly precipitated by upper respiratory tract infections (URTI). Vitamin D deficiency is also very common in the UK. A growing body of evidence from laboratory and clinical studies suggests that vitamin D supplementation may prevent exacerbations of asthma by enhancing both anti-inflammatory and antimicrobial immune responses. 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.
Ethics approval
MREC approved (ref: 09/H0703/67)
Study design
Multicentre randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
Intervention
1. Dietary Supplement: Cholecalciferol + miglyol oil
2. Dietary Supplement: Miglyol oil
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin D
Primary outcome measures
Time to first upper respiratory tract infection at one year
Secondary outcome measures
1. Asthma Control Test Score, measured at one year
2. Time to first severe asthma exacerbation, measured at one year
3. Proportion of participants experiencing hypercalcaemia, measured at one year
4. Time to unscheduled health service use for upper respiratory tract infection or severe asthma exacerbation, measured at one year
Overall trial start date
01/06/2009
Overall trial end date
30/08/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Medical record diagnosis of asthma, treated at British Thoracic Society (BTS) step 2 or above for at least 28 days before first dose of investigational medical product (IMP)
2. One or more of the following, documented within the last 3 years:
2.1. 12% increase in forced expiratory volume in one second (FEV1) after inhalation of 400 micrograms of salbutamol
2.2. 20% diurnal variability in peak expiratory flow
2.3. Methacholine PC20 (concentration of methacholine causing a 20% fall in FEV1) less than 8 g/L
3. Age 12 years and 80 years on day of first dose of IMP, either sex
4. Contactable by telephone and able to attend face-to-face review at 2, 6 and 12 months post-enrolment
5. 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
6. Able to give written informed consent to participate in the study if aged 16 years; if aged less than 16 years, able to give assent, with a parent or guardian able to give written informed consent for the subject to participate in the study
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
Planned sample size: 250
Participant exclusion criteria
1. Diagnosis of COPD as defined by the GOLD guidelines
2. 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
3. Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study
4. Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone
5. Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP
6. Treatment with any investigational medical product or device up to 4 months before first dose of IMP
7. Breastfeeding, pregnant or planning a pregnancy
8. Baseline corrected serum calcium greater than 2.65 mmol/L
9. Baseline serum creatinine greater than 125 micromol/L
10. Smoking history greater than 15 pack-years
11. Severe asthma exacerbation or URTI up to 28 days before first dose of IMP
12. Inability to use spirometer or peak expiratory flow rate (PEFR) meter
13. Inability to complete diary of symptoms and PEFR
Recruitment start date
01/06/2009
Recruitment end date
30/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Health Sciences
London
E1 2AT
United Kingdom
Sponsor information
Organisation
Barts and The London NHS Trust (UK)
Sponsor details
Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary