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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Wai Yee James


Study Location:

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Be Part of Research - Trial Details - Trial of vitamin D supplementation in chronic obstructive pulmonary disease (COPD)

Trial of vitamin D supplementation in chronic obstructive pulmonary disease (COPD)

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Topic: Inflammatory and Immune System
Subtopic: Inflammatory and Immune System (all Subtopics)
Disease: Immunology and inflammation


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

11 Sep 2009 30 Aug 2013

Publications

2014 Results article in https://doi.org/10.1016/S2213-2600(14)70255-3 results

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.


Patients aged 40 years and over and diagnosed with COPD

You can take part if:



You may not be able to take part if:


1. Current diagnosis of asthma2. Known clinically significant bronchiectasis3. Known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin D intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission for 3 years4. Any other condition that, in an investigator's judgement, might compromise patient safety or compliance, interfere with evaluation or preclude completion of the study5. COPD requiring long-term oxygen therapy 12 hours per day6. Taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin or primidone7. Taking dietary supplement containing vitamin D up to 2 months before first dose of IMP8. Treatment with any investigational medical product or device up to 4 months before first dose of IMP9. Breastfeeding, pregnant or planning a pregnancy10. Baseline corrected serum calcium greater than 2.65 mmol/L11. Baseline serum creatinine greater than 125 micromol/L12. Upper respiratory tract infection (URTI) or COPD exacerbation up to 28 days before first dose of IMP13. Inability to use spirometer14. Inability to complete symptom diary


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Centre for Health Sciences
    London
    E1 2AT

Not provided at time of registration

Ms Wai Yee James



The study is sponsored by Barts and The London School of Medicine and Dentistry and funded by National Institute for Health Research.




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Read full details for Trial ID: ISRCTN99876783

Or CPMS 7831

Last updated 03 February 2016

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