Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00977873
Protocol/serial number
7831
Study information
Scientific title
Randomised, multicentre, double-blind, placebo-controlled trial of vitamin D supplementation in patients with chronic obstructive pulmonary disease (COPD)
Acronym
Study hypothesis
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
East London and the City Research Ethics Committees, 24/07/2009, ref: 09/H0703/76
Study design
Multicentre randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Vitamin D
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 trial start date
11/09/2009
Overall trial end date
30/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 240
Participant 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
Recruitment start date
11/09/2009
Recruitment end date
30/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Health Sciences
London
E1 2AT
United Kingdom
Sponsor information
Organisation
Barts and The London School of Medicine and Dentistry
Sponsor details
Blizard Institute of Cell and Molecular Science (ICMS)
The Blizard Building
4 Newark Street
London
E1 2AT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(14)70255-3/fulltext