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 (NCT)	NCT00978315
Protocol serial number	7530
Sponsor	Barts and The London NHS Trust (UK)
Funder	National Institute for Health Research

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

Primary study design	Interventional
Study design	Multicentre randomised interventional prevention trial
Secondary study design	Randomised controlled trial
Study type	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(s)	Time to first upper respiratory tract infection at one year
Key secondary outcome measure(s)	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
Completion date	30/08/2013

Eligibility

Participant type(s)	Patient
Age group	All
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Centre for Health Sciences

London
E1 2AT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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