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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03718182
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Birmingham NHS Foundation Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sheldon C Cooper, Dr
Principal Investigator Affiliation Univeristy Hospital Birmingham NHS Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOther
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease, Vitamin D Deficiency
Arms & Interventions

Arms

Active Comparator: Arm A - Cholecalciferol 400iu

Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)

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).

Interventions

Dietary Supplement: - Cholecalciferol

vitamin D3 daily oral supplement

Contact a Trial Team

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International Sites

Birmingham, West Midlands, United Kingdom

Status

Recruiting

Address

University Hospitals Birmingham NHS Trust

Birmingham, West Midlands, B15 2WG

Site Contact

Jane Fletcher

jane.fletcher@uhb.nhs.uk

0121 371 4561

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