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

NCT03718182 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

  • Crohn Disease
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

vitamin D3 daily oral supplement

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Birmingham

    collaborator OTHER

  • Clinical Trials Research Centre

    collaborator UNKNOWN

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Sheldon C Cooper, Dr · Univeristy Hospital Birmingham NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2020-11-30
Completion
2020-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718182 on ClinicalTrials.gov