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

Primary Purpose

Crohn Disease, Vitamin D Deficiency

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
University Hospital Birmingham NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Birmingham NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A - Cholecalciferol 400iu

Arm B - Cholecalciferol 3200iu/800iu

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Inflammatory Bowel Disease Questionnaire (IBDQ)
Disease Related Quality of life patient reported outcome measure

Secondary Outcome Measures

Euroquol EQ-5D-5L
Generic utility measure patient reported outcome

Full Information

First Posted
October 23, 2018
Last Updated
March 24, 2020
Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Birmingham, Clinical Trials Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03718182
Brief Title
Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy?
Acronym
D-CODE
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom, University of Birmingham, Clinical Trials Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Vitamin D Deficiency
Keywords
vitamin D supplementation, quality of life, Inflammatory Bowel Disease Questionnaire IBDQ, Hepcidin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - Cholecalciferol 400iu
Arm Type
Active Comparator
Arm Description
Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)
Arm Title
Arm B - Cholecalciferol 3200iu/800iu
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
vitamin D3 daily oral supplement
Primary Outcome Measure Information:
Title
Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
Disease Related Quality of life patient reported outcome measure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Euroquol EQ-5D-5L
Description
Generic utility measure patient reported outcome
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Vitamin D 25(OH)D levels
Description
Increase in serum vitamin D levels
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Fletcher
Phone
0121 371 4561
Email
jane.fletcher@uhb.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Sheldon Cooper
Phone
01213714561
Email
jane.fletcher@uhb.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon C Cooper, Dr
Organizational Affiliation
Univeristy Hospital Birmingham NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham NHS Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2WG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Fletcher
Phone
0121 371 4561
Email
jane.fletcher@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sheldon Cooper
Phone
01213714561
Email
jane.fletcher@uhb.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sheldon Cooper

12. IPD Sharing Statement

Citations:
PubMed Identifier
33743801
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.
Results Reference
derived

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

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