D-CODE Feasibility Study
Research type
Research Study
Full title
Can Vitamin D Supplementation in Patients with Crohn's Disease Improve Symptoms as an Adjunct Therapy: D-CODE Feasibility Study
IRAS ID
255005
Contact name
Jane Fletcher
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Eudract number
2018-003910-42
ISRCTN Number
ISRCTN15717783
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Research Summary
Can treating vitamin D deficiency with a daily oral supplement in adults with Crohn’s Disease help to improve symptoms?
There are around 115,000 people in the UK suffering with Crohn’s Disease (CD). CD can cause inflammation and ulcers to develop anywhere within the gut. Symptoms of the disease include diarrhoea, abdominal pain and nutritional problems including vitamin D deficiency. Around half of people with CD are likely to have vitamin D deficiency. Research has shown that treating vitamin D deficiency in people with CD might help to improve the symptoms of the disease. However, there are no clear guidelines on how to detect or treat vitamin D deficiency in people with CD.
There will be two parts to the planned research involving three hospitals in Birmingham. Part 1 is a vitamin D screening study, where adults will be asked to have a finger-prick blood test to check their vitamin D levels. They will asked to answer dietary and lifestyle questions. Adults found to have vitamin D deficiency in part 1 may be invited to join part 2 of the research. Part 2 is a vitamin D supplementation study where participants will be given a daily vitamin D capsule to take by mouth for 24 weeks. They will be randomly allocated to 2 different groups with each group receiving a different dose of vitamin D. There is no control group. Participants will have blood tests at the start,12 weeks and 24 weeks. They will complete quality of life questionnaires at the start and after 24 weeks. The last appointment will be a final follow-up appointment after 36 weeks.
This research is important to help determine:
• Which dose of vitamin D is most effective at treating vitamin D deficiency in people with CD
• If symptoms of CD improve when vitamin D deficiency is treated.Summary of Results
"General information: The study was funded by the National Institute for Health Research (NIHR) via a Clinical Doctoral Research Fellowship. It was sponsored by University Hospitals Birmingham NHS Foundation Trust. A patient and public involvement group called Expert by Experience – IBD, was developed to help design the research and to write patient information materials. In total there were five people involved in the patient group, three of whom had either Crohn’s Disease or another form of Inflammatory Bowel Disease, and two of whom were relatives of sufferers of these diseases.
There were two parts to the research which was carried out at the Queen Elizabeth Hospital Birmingham in the Gastroenterology outpatient department including the infusion unit. Because of the COVID-19 pandemic interrupting research activity, the research was carried out over two separate periods September 2019 to March 2020 and December 2020 to September 2021.There are around 115,000 people in the UK suffering with Crohn’s Disease (CD). CD can cause inflammation and ulcers to develop anywhere within the gut. Symptoms of the disease include diarrhoea, abdominal pain and nutritional problems including vitamin D deficiency. Around half of people with CD are likely to have vitamin D deficiency. Research has shown that treating vitamin D deficiency in people with CD might help to improve the symptoms of the disease. However, there are no clear guidelines on how to identify or treat vitamin D deficiency in people with CD. This research was important to help determine what proportion of people with CD have vitamin D deficiency in Birmingham, which dose of vitamin D is most effective at treating vitamin D deficiency in people with CD, and if symptoms of CD improve when vitamin D deficiency is treated.
Summary of the research: Part 1 was a vitamin D screening study. In this part, 150 adults with CD had a finger-prick blood test to check their vitamin D levels. They answered questions to see if their diet (such as eating oily fish, red meat, eggs, liver, or, food fortified with vitamin D) or lifestyle, such as smoking and exposure of skin to the sun which helps make vitamin D, might influence their vitamin D level. In total 70 men and 80 women took part, most (77.3%) were from a White British background. The results of this part of the research showed that 52.7% of people who took part had vitamin D deficiency, which was a vitamin D blood level of less than 50nmol/L. About a third of people were already taking a vitamin D supplement that they bought over the counter and about a fifth of people had a vitamin D supplement prescribed by a doctor. Diets were generally poor in the main foods that contain vitamin D. The most important of these is oily fish, but less than half of people were eating one to two portions per week. Most people reported that they wore high sun protection factor sun lotion if they were out in the sun. Very few people were smokers.
Some adults with CD and found to have vitamin D deficiency in Part 1 were invited to join Part 2 of the research. Part 2 was a feasibility vitamin D supplementation study where participants were given a daily vitamin D capsule to take by mouth for 24 weeks. If people were already taking a vitamin D supplement that they bought over the counter this was stopped for the study. Participants were randomly allocated to one of two different groups with each group receiving a different dose of vitamin D. The two groups were called Arm A, who were given a capsule with 400IU of vitamin D for 24 weeks, and Arm B who were given a capsule with 3200IU of vitamin D for 12 weeks and then changed to a capsule with 800IU of vitamin D for the final 12 weeks. Participants had blood tests at the start, after 12 weeks and after 24 weeks and were asked to give a stool sample at the start and after 24 weeks. They also completed quality of life questionnaires at the start and after 24 weeks to see if their symptoms had changed. The last appointment was a final follow-up appointment after 28 weeks.
In total 22 people took part, with 11 people in each Arm A and B. There were 12 men and 10 women with an average age of around 38 years. Because Part 2 was a feasibility study the results were not analysed to show a difference between the different doses of vitamin D. The purpose of a feasibility study was to see if participants can take the vitamin D supplements, have blood tests, and complete the questionnaires without any problems. If so, this would mean that it is feasible to repeat the study but with a much larger group of people, which would give more reliable results than a small number. In this part of the research, most participants reported that they had taken all or most of their vitamin D supplements. There were no serious adverse events or significant side effects reported from taking the supplements, although a few people found they need to stop due to gut upset or mild reactions. The vitamin D level of all participants increased with the vitamin D supplements but it increased more quickly and to a higher level within Arm B, where participants were given a higher dose. Participants had all the blood tests they were asked to have and completed nearly all the questionnaires. The main thing that participants found difficult was the provision of a stool sample.
How has this study helped patients and researchers? This research has shown us that many people with CD are likely to have vitamin D deficiency, even when they take over-the-counter vitamin supplements. People with CD are unlikely to improve their vitamin D levels through their diet. The vitamin D supplementation study is safe and feasible, which means it would be possible to repeat this with a larger number of people. A larger study will help determine which dose of vitamin D is most effective for people with CD. The quality of life questionnaires will help to determine if their symptoms improve with the vitamin D supplements, and guide doctors in deciding if these should be part of the normal treatment for people with CD."
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0019
Date of REC Opinion
6 Feb 2019
REC opinion
Favourable Opinion