NCT03718182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

September 17, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

October 23, 2018

Last Update Submit

March 24, 2020

Conditions

Crohn DiseaseVitamin D Deficiency

Keywords

vitamin D supplementationquality of lifeInflammatory Bowel Disease Questionnaire IBDQHepcidin

Outcome Measures

Primary Outcomes (1)

  • Inflammatory Bowel Disease Questionnaire (IBDQ)

    Disease Related Quality of life patient reported outcome measure

    6 months

Secondary Outcomes (1)

  • Euroquol EQ-5D-5L

    6 months

Other Outcomes (1)

  • Vitamin D 25(OH)D levels

    6 months

Study Arms (2)

Arm A - Cholecalciferol 400iu

ACTIVE COMPARATOR

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

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).

Dietary Supplement: Cholecalciferol

Interventions

CholecalciferolDIETARY_SUPPLEMENT

vitamin D3 daily oral supplement

Arm A - Cholecalciferol 400iuArm B - Cholecalciferol 3200iu/800iu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Trust

Birmingham, West Midlands, B15 2WG, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33743801DERIVED

MeSH Terms

Conditions

Crohn DiseaseVitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Sheldon C Cooper, Dr

    Univeristy Hospital Birmingham NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Fletcher

CONTACT

0121 371 4561jane.fletcher@uhb.nhs.uk

Sheldon Cooper

CONTACT

01213714561jane.fletcher@uhb.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutrition Nurse Lead

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 24, 2018

Study Start

September 17, 2019

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

GB(1)