ResolveD-CAP v1.0
Research type
Research Study
Full title
A prospective randomised placebo-controlled study of the influence of vitamin D supplementation on resolution of inflammation following community-acquired pneumonia
IRAS ID
208073
Contact name
Adrian Martineau
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Research Summary
Previous research has shown that people who have been hospitalised for pneumonia are more likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months after their illness. This risk is linked to raised levels of inflammation. Laboratory research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very common in the UK. We are conducting this study to find out if taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.
In our study, we will involve 50 adult participants aged 50 years or older who are deficient in vitamin D and who have recently been hospitalised with pneumonia at Barts Health NHS Trust. We will ask half of the participants to take capsules which contain vitamin D and the other half to take capsules which do not contain vitamin D or any active substance (placebo) for 6 weeks, once they have completed their course of antibiotics. There is an equal chance (1 in 2) that participants will be given either study medication – this allows the two groups to be fairly similar in background characteristics so that we can put down any differences in inflammation to vitamin D supplementation. Neither the study researchers nor the participants will know which study medication the participants are taking during the study, so that the type of study medication does not influence the researchers’ or the participants’ behaviour during the study. We will take blood and coughing samples, fill out symptom questionnaires and perform CT scans for each participant twice during the study, before and after their 6-week course of study medication. We will perform laboratory tests to measure markers of inflammation on the blood and coughing samples. We will analyse the symptom questionnaire scores and CT scans to quantify inflammation.
Summary of Results
Regrettably, this study closed prematurely, with only 3 participants recruited. No results are available.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Ccamdenandkingscross.rec%40hra.nhs.uk%7C2cf270a0a1544da3eacc08dbba73c202%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638308778559272759%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=mQJ3FM1mJDmYGN4YsTr9eYc12eZYo%2F2zQ35mS5uE2Jk%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: No
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected:
If no, explain why you didn't follow it: Not applicable due to study closing early.
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: No results available due to study closing early.
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Not applicable due to study closing early.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL: Not applicable due to study closing early.
If no, explain why: Not applicable due to study closing early.Regrettably, this study closed prematurely, with only 3 participants recruited. No results are available.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/1305
Date of REC Opinion
26 Aug 2016
REC opinion
Further Information Favourable Opinion