Randomised, multi-centre, double-blind, placebo-controlled trial of vitamin D supplementation in adult and adolescent patients with asthma
ISRCTN | ISRCTN07270894 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN07270894 |
ClinicalTrials.gov number | NCT00978315 |
Secondary identifying numbers | 7530 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Beverley Maclaughlin
Scientific
Scientific
Centre for Health Sciences
Abernethy Building 2
Newark Street
London
E1 2AT
United Kingdom
Study information
Study design | Multicentre randomised interventional prevention trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Prevention |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Randomised, multi-centre, double-blind, placebo-controlled prevention trial of vitamin D supplementation in adult and adolescent patients with asthma |
Study acronym | Trial of vitamin D supplementation in asthma |
Study objectives | 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(s) | MREC approved (ref: 09/H0703/67) |
Health condition(s) or problem(s) studied | Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory |
Intervention | 1. Dietary Supplement: Cholecalciferol + miglyol oil 2. Dietary Supplement: Miglyol oil |
Intervention type | Supplement |
Primary outcome measure | 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 study start date | 01/06/2009 |
Completion date | 30/08/2013 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | All |
Sex | Both |
Target number of participants | Planned sample size: 250 |
Total final enrolment | 250 |
Key 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 |
Key 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 |
Date of first enrolment | 01/06/2009 |
Date of final enrolment | 30/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Health Sciences
London
E1 2AT
United Kingdom
E1 2AT
United Kingdom
Sponsor information
Barts and The London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom
Website | http://www.bartsandthelondon.nhs.uk/ |
---|---|
https://ror.org/00b31g692 |
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 01/05/2015 | Yes | No | ||
HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/11/2022: Total final enrolment added.
20/06/2022: Internal review.
26/03/2018: Publication reference added. ClinicalTrials.gov number added.
04/02/2016: No publications found, verifying study status with principal investigator