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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03718182
• Date of registration: 23/10/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital Birmingham NHS Foundation Trust
• Public title: Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE
• Scientific title: Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial
• Date of first enrolment: September 17, 2019
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03718182
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Jane Fletcher

• Name: Jane Fletcher

• Name: Sheldon C Cooper, Dr
• Affiliation: Univeristy Hospital Birmingham NHS Trust

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vitamin D Deficiency

Crohn Disease

Intervention(s)

Dietary Supplement: Cholecalciferol

Primary Outcome(s)

Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: 6 months]

Secondary Outcome(s)

Euroquol EQ-5D-5L [Time Frame: 6 months]

Secondary ID(s)

RRK6542

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute for Health Research, United Kingdom

Clinical Trials Research Centre

University of Birmingham