Study Summary
This trial aims to study the effects of vitamin D treatment on expression of α4β7 on B cells, and determine the effects of vitamin D treatment on gut microbiome composition and BCR repertoire in patients with inflammatory bowel disease.
Eligible Conditions
- Inflammatory Bowel Disease
- Crohn's Disease
- Ulcerative Colitis
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Week 12
Week 12
Decrease cohort mean fecal calprotectin or C-reactive protein (CRP) by 50%.
Decrease in disease activity index scores by 50%
Increase in serum vitamin D (25(OH)D levels by 10 ng/mL
Reduction in immunoglobulin coating of commensal gut bacteria by 20%.
Reduction in α4β7+ B cells by 20%
Trial Safety
Phase-Based Safety
Side Effects for
Risedronate
12%Back pain
7%Arthralgia
3%Fall
1%Osteoarthritis
1%Hip fracture
1%Humerus fracture
1%Lumbar vertebral fracture
1%Femur fracture
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1 Treatment Group
Vitamin D 50,000 IU PO every week
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Vitamin D · No Placebo Group · Phase 1
Vitamin D 50,000 IU PO every week
Drug
Experimental Group · 1 Intervention: Vitamin D · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 12
Who is running the clinical trial?
Doris Duke Charitable FoundationOTHER
48 Previous Clinical Trials
233,196 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,221 Previous Clinical Trials
34,903,548 Total Patients Enrolled
John Mark Gubatan, MDPrincipal InvestigatorStanford University
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Adults who have either ulcerative colitis or Crohn's disease.
You are not taking high doses of vitamin D supplements currently.
You have not had any surgeries to remove part of your bowel.
You have not taken antibiotics in the last 3 months.
Who else is applying?
What state do they live in?
| California | 100.0% |
What site did they apply to?
| Stanford University School of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Most responsive sites:
- Stanford University School of Medicine: < 48 hours
Average response time
- < 2 Days
References
- de Souza, Heitor S. P., Claudio Fiocchi, and Dimitrios Iliopoulos. 2017. “The IBD Interactome: An Integrated View of Aetiology, Pathogenesis and Therapy”. Nature Reviews Gastroenterology & Hepatology. Springer Science and Business Media LLC. doi:10.1038/nrgastro.2017.110.
- Rengarajan, Sunaina, Emily E. Vivio, Miles Parkes, Daniel A. Peterson, Elisha D.O. Roberson, Rodney D. Newberry, Matthew A. Ciorba, and Chyi-Song Hsieh. 2019. “Dynamic Immunoglobulin Responses to Gut Bacteria During Inflammatory Bowel Disease”. Gut Microbes. Informa UK Limited. doi:10.1080/19490976.2019.1626683.
- Castro-Dopico, Tomas, Thomas W. Dennison, John R. Ferdinand, Rebeccah J. Mathews, Aaron Fleming, Dean Clift, Benjamin J. Stewart, et al.. 2019. “Anti-commensal Igg Drives Intestinal Inflammation and Type 17 Immunity in Ulcerative Colitis”. Immunity. Elsevier BV. doi:10.1016/j.immuni.2019.02.006.
- Sigmundsdottir, Hekla, Junliang Pan, Gudrun F Debes, Carsten Alt, Aida Habtezion, Dulce Soler, and Eugene C Butcher. 2007. “Dcs Metabolize Sunlight-induced Vitamin D3 to 'program' T Cell Attraction to the Epidermal Chemokine CCL27”. Nature Immunology. Springer Science and Business Media LLC. doi:10.1038/ni1433.
- Gubatan, John, Naomi D. Chou, Ole Haagen Nielsen, and Alan C. Moss. 2019. “Systematic Review with Meta-analysis: Association of Vitamin D Status with Clinical Outcomes in Adult Patients with Inflammatory Bowel Disease”. Alimentary Pharmacology & Therapeutics. Wiley. doi:10.1111/apt.15506.
- Gubatan, John, Samuel J S Rubin, Lawrence Bai, Yeneneh Haileselassie, Steven Levitte, Tatiana Balabanis, Akshar Patel, Arpita Sharma, Sidhartha R Sinha, and Aida Habtezion. 2021. “Vitamin D Is Associated with Α4β7+ Immunophenotypes and Predicts Vedolizumab Therapy Failure in Patients with Inflammatory Bowel Disease”. Journal of Crohn's and Colitis. Oxford University Press (OUP). doi:10.1093/ecco-jcc/jjab114.
- Gubatan, John, Shuji Mitsuhashi, Talia Zenlea, Laura Rosenberg, Simon Robson, and Alan C. Moss. 2017. “Low Serum Vitamin D During Remission Increases Risk of Clinical Relapse in Patients with Ulcerative Colitis”. Clinical Gastroenterology and Hepatology. Elsevier BV. doi:10.1016/j.cgh.2016.05.035.
- Caruso, Roberta, Bernard C. Lo, and Gabriel Núñez. 2020. “Host–microbiota Interactions in Inflammatory Bowel Disease”. Nature Reviews Immunology. Springer Science and Business Media LLC. doi:10.1038/s41577-019-0268-7.
- Gubatan, John, and Alan C. Moss. 2018. “Vitamin D in Inflammatory Bowel Disease”. Current Opinion in Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mog.0000000000000449.
- Gubatan, John, Samuel J S Rubin, Lawrence Bai, Yeneneh Haileselassie, Steven Levitte, Tatiana Balabanis, Akshar Patel, Arpita Sharma, Sidhartha R Sinha, and Aida Habtezion. 2021. “Vitamin D Is Associated with Α4β7+ Immunophenotypes and Predicts Vedolizumab Therapy Failure in Patients with Inflammatory Bowel Disease”. Journal of Crohn's and Colitis. Oxford University Press (OUP). doi:10.1093/ecco-jcc/jjab114.
- Gubatan J, Rubin SJS, Bai L, Haileselassie Y, Levitte S, Balabanis T, Patel A, Sharma A, Sinha SR, Habtezion A. Vitamin D Is Associated with alpha4beta7+ Immunophenotypes and Predicts Vedolizumab Therapy Failure in Patients with Inflammatory Bowel Disease. J Crohns Colitis. 2021 Dec 18;15(12):1980-1990. doi: 10.1093/ecco-jcc/jjab114.
- de Souza HSP, Fiocchi C, Iliopoulos D. The IBD interactome: an integrated view of aetiology, pathogenesis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Dec;14(12):739-749. doi: 10.1038/nrgastro.2017.110. Epub 2017 Aug 23.
- Caruso R, Lo BC, Nunez G. Host-microbiota interactions in inflammatory bowel disease. Nat Rev Immunol. 2020 Jul;20(7):411-426. doi: 10.1038/s41577-019-0268-7. Epub 2020 Jan 31.
- Gubatan J, Moss AC. Vitamin D in inflammatory bowel disease: more than just a supplement. Curr Opin Gastroenterol. 2018 Jul;34(4):217-225. doi: 10.1097/MOG.0000000000000449.
- Sigmundsdottir H, Pan J, Debes GF, Alt C, Habtezion A, Soler D, Butcher EC. DCs metabolize sunlight-induced vitamin D3 to 'program' T cell attraction to the epidermal chemokine CCL27. Nat Immunol. 2007 Mar;8(3):285-93. doi: 10.1038/ni1433. Epub 2007 Jan 28.
- John Gubatan 2021. "Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828031.
Frequently Asked Questions
Can excessive Vitamin D intake be detrimental to one's health?
"Our research team at Power assigned the safety of Vitamin D a score of 1, as this is just an early-stage trial with limited evidence for its efficacy and safety." - Anonymous Online Contributor
Unverified Answer
What is the enrolment capacity for this clinical study?
"Affirmative. Information hosted on clinicaltrials.gov affirms that this medical trial is currently enrolling participants, with the first posting date being July 1st 2021 and most recent update occurring on October 24th 2022. The research team seeks to recruit 50 patients from a single site." - Anonymous Online Contributor
Unverified Answer
What other research has been undertaken to assess the efficacy of Vitamin D?
"Presently, there are 33 research studies studying Vitamin D. Of those live trials, 11 have reached the Phase 3 stage. While many of these investigations for Vitamin D originate from Valdemoro in Madrid, 88 other locations worldwide are conducting related experiments." - Anonymous Online Contributor
Unverified Answer
Is the enrollment phase of this research venture still open?
"Affirmative. Details found on clinicaltrials.gov confirm that this scientific inquiry, which was initially posted on July 1st 2021, is in need of participants. Approximately 50 individuals must be recruited from one medical centre." - Anonymous Online Contributor
Unverified Answer