Crohn Disease, Vitamin D Deficiency
Conditions
Keywords
vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin
Brief summary
There are around 115,000 people in the United Kingdom 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 complete short diet and lifestyle questionnaires. 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 6 months. They will be randomly allocated to 2 different groups with each group receiving a different dose of vitamin D. Participants will have blood tests at the start, after 3 months and after 6 months. They will complete quality of life questionnaires at the start and after 6 months. The last appointment will be a final follow up appointment after 9 months. 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.
Interventions
DIETARY_SUPPLEMENTCholecalciferol
vitamin D3 daily oral supplement
Sponsors
National Institute for Health Research, United Kingdom
University of Birmingham
Clinical Trials Research Centre
University Hospital Birmingham NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
D-CODE is a two part trial entailing two vitamin D screening studies (winter and summer) and an interventional feasibility study. The vitamin D screening studies will take place during the winter and summer months to determine the prevalence of vitamin D deficiency in patients with CD throughout the seasons. In the intervention/feasibility stage D-CODE is an exploratory study for an open label, multi-site, superiority randomised controlled trial. Participants will be randomised to one of two parallel arms (A or B)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. VITAMIN D SCREENING STUDY Those: * With a confirmed diagnosis of Crohn's Disease (CD) * ≥ 18 years of age * Have provided written informed consent 2. VITAMIN D SUPPLEMENTATION FEASIBILITY TRIAL Those: * With a confirmed diagnosis of CD * Identified as having Vitamin D deficiency \< 50 nmol/L in the Winter screening study * ≥ 18 years of age * Already receiving treatment for CD as per National Institute for Health and Care Excellence (NICE) Guidance or those in remission and not currently receiving treatment but who continue to attend hospital out-patient appointments * Have provided written informed consent
Exclusion criteria
1. VITAMIN D SCREENING STUDY * None 2. VITAMIN D SUPPLEMENTATION FEASIBILITY Those: * Currently receiving vitamin D, fish oil or multi-vitamin supplementation and unwilling to stop this to participate in the feasibility trial * Currently receiving: * Bisphosphonates * Digitalis or other cardiac glycosides * Phenytoin * Barbituates (e.g. Amylobarbitone, Butobarbitone, Methyl Phenobarbitone, Pentobarbitone, Quinalbarbitone, Amylobarbitone) * Actinomycin * Imidazole * With known hyperparathyroidism * With known sarcoidosis * With known renal disease or kidney stones * With known hypercalcaemia (corrected serum calcium ≥2.60 mmol/L) * With known underlying liver disease * With known hypersensitivity to vitamin D supplements or any of the trial medication excipients * Who are pregnant, breast feeding, trying to conceive or women of child-bearing age who decline to have a pregnancy test where applicable. Women who have had a hysterectomy, bilateral oophorectomy or early menopause will not require a pregnancy test. * Individuals who have participated in a trial testing a medicinal product within 6 months preceding screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Bowel Disease Questionnaire (IBDQ) | 6 months | Disease Related Quality of life patient reported outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Euroquol EQ-5D-5L | 6 months | Generic utility measure patient reported outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D 25(OH)D levels | 6 months | Increase in serum vitamin D levels |
Countries
United Kingdom
Contacts
Primary ContactJane Fletcher
Backup ContactSheldon Cooper
Outcome results
None listed