Status:
COMPLETED
Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Inflammatory Bowel Diseases
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Specific Aim 1: Characterize the effects of vitamin D treatment on expression of α4β7 on B cells in patients with inflammatory bowel disease (IBD). Specific Aim 2: Determine the effects of vitamin D ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04828031
Start Date
July 1 2021
End Date
July 1 2023
Last Update
September 21 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305