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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT04828031
• Date of registration: 29/03/2021
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease
• Scientific title: Vitamin D Regulation of a4ß7+ B Cell Immunophenotypes and Mucosal Antibody Response to Commensal Gut Bacteria in Patients With Inflammatory Bowel Disease
• Date of first enrolment: July 1, 2021
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04828031
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: John Mark Gubatan, MD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

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



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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Inflammatory Bowel Diseases

Crohn Disease

Intervention(s)

Drug: Vitamin D

Primary Outcome(s)

Reduction in a4ß7+ B cells by 20% [Time Frame: Week 12]

Reduction in immunoglobulin coating of commensal gut bacteria by 20%. [Time Frame: Week 12]

Secondary Outcome(s)

Decrease in disease activity index scores by 50% [Time Frame: Week 12]

Decrease cohort mean fecal calprotectin or C-reactive protein (CRP) by 50%. [Time Frame: Week 12]

Increase in serum vitamin D (25(OH)D levels by 10 ng/mL [Time Frame: Week 12]

Secondary ID(s)

IRB-60958

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Doris Duke Charitable Foundation