Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?

Study Overview
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Brief Summary
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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.

Official Title
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Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial

Conditions
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Crohn Disease, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: VITAMIN D SCREENING STUDY Those: With a confirmed diagnosis of Crohn's Disease (CD) ≥ 18 years of age Have provided written informed consent 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: VITAMIN D SCREENING STUDY None 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A - Cholecalciferol 400iu<br>Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months) | Dietary Supplement: Cholecalciferol<br>* vitamin D3 daily oral supplement<br>|
| Experimental: Arm B - Cholecalciferol 3200iu/800iu<br>Vitamin D3 (Cholecalciferol) supplement 3,200iu daily oral capsule. To be taken for 12 weeks (3 months). Then switch to vitamin D3 supplement 800iu daily oral capsule. To be taken for 12 weeks (3 months). | Dietary Supplement: Cholecalciferol<br>* vitamin D3 daily oral supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Disease Related Quality of life patient reported outcome measure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euroquol EQ-5D-5L | Generic utility measure patient reported outcome | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin