Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease

Plain-language summary

This study examines the effect of Vitamin D on gut-specific immune cells in people with inflammatory bowel disease. It enrolled adults aged 18 and older with ulcerative colitis or Crohn's disease who had low blood vitamin D levels. It was conducted in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Stanford University

Intervention

Vitamin D

Start date

7/1/2021

Estimated completion

7/1/2023

Countries

United States

Related genes

Locations

• Stanford, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Adult patients (18 years or older) with inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Low serum vitamin D (25(OH)D ≤ 25 ng/mL
* Not currently on high dose vitamin D supplementation
* No prior bowel resections
* No antibiotic use in past 3 months.

Exclusion Criteria:

* Patients less than 18 years old
* No diagnosis of IBD
* Serum 25(OH)D \> 25 ng/mL
* Patients already on vitamin D supplementation
* Prior history of bowel surgery (colectomy or small bowel resections)
* Recent antibiotic use in past 3 months
* Renal Dysfunction
* History of Hypercalcemia
* History of HIV
* History of IgA deficiency
* History of Common Variable Immunodeficiency (CVID)
* Active C. diff infection