Clinical trial NCT03718182: Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?
Official title: Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn Disease
Vitamin D Deficiency
Keywords: vitamin D supplementation
quality of life
Inflammatory Bowel Disease Questionnaire IBDQ
Hepcidin
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Birmingham
name: Clinical Trials Research Centre
First posted: 2018-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 6 months
Secondary outcomes:
measure: Euroquol EQ-5D-5L
timeFrame: 6 months
Other outcomes:
measure: Vitamin D 25(OH)D levels
timeFrame: 6 months
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Trust
state: West Midlands
Study officials:
affiliation: Univeristy Hospital Birmingham NHS Trust
name: Sheldon C Cooper, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fletcher J, Bedson E, Brown M, Hewison M, Swift A, Cooper SC. Protocol for an open-label feasibility study for a randomised controlled trial of vitamin D supplementation in Crohn's Disease patients with vitamin D deficiency: D-CODE Feasiblity study. Pilot Feasibility Stud. 2021 Mar 20;7(1):79. doi: 10.1186/s40814-021-00813-3.