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

Centre for Health Sciences
Abernethy Building 2
Newark Street
London
E1 2AT
United Kingdom

Study information

Study designMulticentre randomised interventional prevention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleRandomised, multi-centre, double-blind, placebo-controlled prevention trial of vitamin D supplementation in adult and adolescent patients with asthma
Study acronymTrial of vitamin D supplementation in asthma
Study objectivesAsthma 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) studiedTopic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
Intervention1. Dietary Supplement: Cholecalciferol + miglyol oil
2. Dietary Supplement: Miglyol oil
Intervention typeSupplement
Primary outcome measureTime to first upper respiratory tract infection at one year
Secondary outcome measures1. 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 date01/06/2009
Completion date30/08/2013

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participantsPlanned sample size: 250
Total final enrolment250
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2009
Date of final enrolment30/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Health Sciences
London
E1 2AT
United Kingdom

Sponsor information

Barts and The London NHS Trust (UK)
Hospital/treatment centre

Queen Mary's Innovation Centre
5 Walden Street
London
E1 2EF
England
United Kingdom

Website http://www.bartsandthelondon.nhs.uk/
ROR logo "ROR" https://ror.org/00b31g692

Funders

Funder type

Government

National Institute for Health Research
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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