Crohn DiseasePhase 4D-CODENCT03718182
Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?
A Phase 4 study testing Cholecalciferol in people with Crohn Disease and Vitamin D Deficiency, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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:
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Trust
Birmingham, West Midlands, B15 2WG
Jane Fletcher, 0121 371 4561, jane.fletcher@uhb.nhs.uk
Sheldon Cooper, 01213714561, jane.fletcher@uhb.nhs.uk
About this study
Official title: Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial
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.
Read more
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.
- Conditions
- Crohn Disease, Vitamin D Deficiency
- Being tested
- Cholecalciferol
- Keywords
- vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin
- Medical subject headings
- Crohn Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
vitamin D3 daily oral supplement
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Cholecalciferol 400iu | Active comparator | Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months) Receives: Dietary Supplement: Cholecalciferol |
| Arm B - Cholecalciferol 3200iu/800iu | Experimental | 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). Receives: Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Bowel Disease Questionnaire (IBDQ)
Disease Related Quality of life patient reported outcome measure
Measured: 6 months
Secondary outcomes (1)
Euroquol EQ-5D-5L
Generic utility measure patient reported outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start17 Sep 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Birmingham, Clinical Trials Research Centre
- Responsible party
- Principal investigator, Jane Fletcher, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Sheldon C Cooper, Dr, Principal investigator, Univeristy Hospital Birmingham NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718182
- Sponsor's protocol ID
- RRK6542
- Acronym
- D-CODE
- Status last verified
- Mar 2020
- First submitted
- 23 Oct 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33743801
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03718182
- Acronym / sponsor ID
- D-CODE / RRK6542
- Conditions
- Crohn Disease, Vitamin D Deficiency
- Keywords
- vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Birmingham, Clinical Trials Research Centre
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Arm A - Cholecalciferol 400iu | Active comparator | Dietary Supplement: CholecalciferolVitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months) |
| Arm B - Cholecalciferol 3200iu/800iu | Experimental | Dietary Supplement: CholecalciferolVitamin 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- VITAMIN D SCREENING STUDY
- VITAMIN D SUPPLEMENTATION FEASIBILITY TRIAL
- With a confirmed diagnosis of CD
- Identified as having Vitamin D deficiency < 50 nmol/L in the Winter screening study
- ≥ 18 years of age
Key exclusion criteria (20 listed)
- VITAMIN D SCREENING STUDY
- VITAMIN D SUPPLEMENTATION FEASIBILITY
- Currently receiving vitamin D, fish oil or multi-vitamin supplementation and unwilling to stop this to participate in the feasibility trial
- Currently receiving:
- With known hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferolvitamin D3 daily oral supplement | Dietary supplement | Arm A - Cholecalciferol 400iu, Arm B - Cholecalciferol 3200iu/800iu |
Primary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 6 months
Disease Related Quality of life patient reported outcome measure
1 secondary outcome
Euroquol EQ-5D-5L
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 33743801Fletcher 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.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon C Cooper, Dr principal investigator
Univeristy Hospital Birmingham NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Crohn Disease and Vitamin D Deficiency, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Fletcher (0121 371 4561, jane.fletcher@uhb.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Bowel Disease Questionnaire (IBDQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.