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

Crohn Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03718182
• Other study ID #: RRK6542
• Status: Recruiting
• Phase: Phase 4
• Start date: September 17, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: Jane Fletcher
• Phone: 0121 371 4561
• Email: jane.fletcher[@]uhb.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol
vitamin D3 daily oral supplement

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Trust	Birmingham	West Midlands

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust	Clinical Trials Research Centre, National Institute for Health Research, United Kingdom, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitamin D 25(OH)D levels	Increase in serum vitamin D levels	6 months
Primary	Inflammatory Bowel Disease Questionnaire (IBDQ)	Disease Related Quality of life patient reported outcome measure	6 months
Secondary	Euroquol EQ-5D-5L	Generic utility measure patient reported outcome	6 months