Topic: Respiratory
Conditions
Interventions
1. Dietary Supplement: Cholecalciferol + miglyol oil
2. Dietary Supplement: Miglyol oil
Sponsors
Barts and The London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first upper respiratory tract infection at one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed