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

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.

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 Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency; Crohn Disease
• Intervention / Treatment: Dietary supplement: Cholecalciferol

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2WG
      • Recruiting
      • University Hospitals Birmingham NHS Trust
      • Contact: Jane Fletcher; Phone Number: 0121 371 4561; Email: jane.fletcher@uhb.nhs.uk
      • Contact: Sheldon Cooper; Phone Number: 01213714561; Email: jane.fletcher@uhb.nhs.uk
      • Principal Investigator: Sheldon Cooper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A - Cholecalciferol 400iu; Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)	Dietary supplement: Cholecalciferol; vitamin D3 daily oral supplement
Experimental: 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).	Dietary supplement: Cholecalciferol; vitamin D3 daily oral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Bowel Disease Questionnaire (IBDQ)	Disease Related Quality of life patient reported outcome measure	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euroquol EQ-5D-5L	Generic utility measure patient reported outcome	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D 25(OH)D levels	Increase in serum vitamin D levels	6 months

Collaborators and Investigators

• Sponsor: University Hospital Birmingham NHS Foundation Trust
• Collaborators: University of Birmingham; National Institute for Health Research, United Kingdom; Clinical Trials Research Centre
• Investigators: Principal Investigator: Sheldon C Cooper, Dr, Univeristy Hospital Birmingham NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; Hepcidin; vitamin D supplementation; Inflammatory Bowel Disease Questionnaire IBDQ
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Vitamin D Deficiency; Crohn Disease; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: RRK6542

Drug and device information, study documents

• 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