Trial of vitamin D supplementation in chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN99876783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99876783 |
| ClinicalTrials.gov number | NCT00977873 |
| Secondary identifying numbers | 7831 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 03/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Vitamin D - the sunshine vitamin - is best known for its effects on bone health. Profound deficiency causes rickets, a condition that causes the bones on children to become soft and weak, which, in turn, can lead to bone deformities. More moderate deficiency, commonly seen in the UK during winter and spring, can make people more susceptible to respiratory infections. Respiratory infections cause 20% of GP consultations, 300,000 hospital admissions and 30,000 deaths per year. Patients with chronic obstructive pulmonary disease (COPD) are at high risk of such infections. Studies have shown that vitamin D 'switches on' the production of natural antibiotic substances that can kill viruses and bacteria in cells that fight infection. One small study, originally designed to look at the effects of vitamin D on bone health has shown that patients receiving high-dose vitamin D were 3 times less likely to have cold and 'flu symptoms than those who received placebo (dummy pill). The primary aim of the study is to determine whether vitamin D supplementation is a cost-effective and acceptable way to reduce acute respiratory illness in patients with COPD.
Who can participate?
Patients aged 40 years and over and diagnosed with COPD
What does the study involve?
Participants are randomly allocated to one of two groups. Those no group 1 are given Vigantol (a form of vitamin D). Those in group 2 are given a placebo. All participants attend five study visits over the course of a year and are also contacted by telephone on five occasions at intervals between scheduled visits. Participants are asked to complete a daily diary of chest symptoms, give blood samples and perform breathing and muscle strength tests at the beginning, the middle and the end of the study.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A number of GP surgeries in London and Norfolk.
When is the study starting and how long is it expected to run for?
September 2009 to August 2013
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Wai Yee James
Contact information
Scientific
Centre for Health Sciences
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 the contact details below to request a patient information sheet |
| Scientific title | Randomised, multicentre, double-blind, placebo-controlled trial of vitamin D supplementation in patients with chronic obstructive pulmonary disease (COPD) |
| Study objectives | The primary aim of the study is to determine whether vitamin D supplementation is a cost-effective and acceptable strategy to reduce acute respiratory illness in patients with COPD. |
| Ethics approval(s) | East London and the City Research Ethics Committees, 24/07/2009, ref: 09/H0703/76 |
| Health condition(s) or problem(s) studied | Topic: Inflammatory and Immune System; Subtopic: Inflammatory and Immune System (all Subtopics); Disease: Immunology and inflammation |
| Intervention | Vigantol, 3 mg or miglyol oil (placebo), to be administered every two months over a twelve months period, in total of six doses. Patients will be followed up at these post-dose time points: 2 months, 6 months and 12 months. |
| Intervention type | Supplement |
| Primary outcome measure | Time from randomisation to first moderate or severe COPD exacerbation |
| Secondary outcome measures | Respiratory morbidity. Measured at screen visit, randomisation visit, 2 months post-dose, 6 months post-dose and 12 months post-dose. |
| Overall study start date | 11/09/2009 |
| Completion date | 30/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 240 |
| Key inclusion criteria | 1. Medical record diagnosis of COPD, emphysema or bronchitis 2. Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70% or post-bronchodilator FEV1/slow vital capacity (VC) less than 70% 3. Post-bronchodilator FEV1 less than 80% predicted 4. Age 40 years on day of first dose of IMP, either sex 5. Smoking history 15 pack-years 6. Exacerbation of COPD requiring treatment with antibiotics and/or systemic corticosteroids within 12 months of screening visit 7. Contactable by telephone and able to attend face-to-face review at 2, 6 and 12 months post-enrolment 8. 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 9. Able to give written informed consent to participate |
| Key exclusion criteria | 1. Current diagnosis of asthma 2. Known clinically significant bronchiectasis 3. 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 4. Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study 5. COPD requiring long-term oxygen therapy 12 hours per day 6. Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone 7. Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP 8. Treatment with any investigational medical product or device up to 4 months before first dose of IMP 9. Breastfeeding, pregnant or planning a pregnancy 10. Baseline corrected serum calcium greater than 2.65 mmol/L 11. Baseline serum creatinine greater than 125 micromol/L 12. Upper respiratory tract infection (URTI) or COPD exacerbation up to 28 days before first dose of IMP 13. Inability to use spirometer 14. Inability to complete symptom diary |
| Date of first enrolment | 11/09/2009 |
| Date of final enrolment | 30/08/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
E1 2AT
United Kingdom
Sponsor information
University/education
Blizard Institute of Cell and Molecular Science (ICMS)
The Blizard Building
4 Newark Street
London
E1 2AT
England
United Kingdom
| Website | http://www.icms.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00b31g692 |
Funders
Funder type
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/02/2016: Publication reference added. Plain English summary added.
