A Phase 4 interventional study of Cholecalciferol in Crohn Disease and Vitamin D Deficiency, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Phase 4, Interventional, and Treatment
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:
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
VITAMIN D SCREENING STUDY
Those:
Those:
Exclusion Criteria:
VITAMIN D SCREENING STUDY
Those:
Currently receiving:
Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)
Dietary Supplement: Cholecalciferol
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
Inflammatory Bowel Disease Questionnaire (IBDQ)
Disease Related Quality of life patient reported outcome measure
Time frame: 6 months
Euroquol EQ-5D-5L
Generic utility measure patient reported outcome
Time frame: 6 months
Vitamin D 25(OH)D levels
Increase in serum vitamin D levels
Time frame: 6 months
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust