Condition category
Respiratory
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
03/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Ms Wai Yee James

ORCID ID

Contact details

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

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 measures

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

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

http://www.icms.qmul.ac.uk/

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

Results - basic reporting

Publication summary

2014 results in: http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(14)70255-3/fulltext

Publication citations

Additional files

Editorial Notes

03/02/2016: Publication reference added. Plain English summary added.