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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-17

Study Completion Date

2020-12-31

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.

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Detailed Description

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Conditions

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Crohn Disease Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A - Cholecalciferol 400iu

Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

vitamin D3 daily oral supplement

Arm B - Cholecalciferol 3200iu/800iu

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).

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

vitamin D3 daily oral supplement

Interventions

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Cholecalciferol

vitamin D3 daily oral supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No