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Vitamin Supplement

Vitamin D for Inflammatory Bowel Disease

Phase 1

Waitlist Available

Led By John Mark Gubatan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

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
Ulcerative Colitis
Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in immunoglobulin coating of commensal gut bacteria by 20%.

Reduction in α4β7+ B cells by 20%

Secondary outcome measures

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

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110

12%

Back pain

Arthralgia

Fall

Hip fracture

Humerus fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

Study treatment Arm

Risedronate

Teriparatide

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vitamin D 50,000 IU PO every weekExperimental Treatment1 Intervention

Vitamin D 50,000 IU PO every week for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Doris Duke Charitable FoundationOTHER

61 Previous Clinical Trials

260,077 Total Patients Enrolled

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,960 Total Patients Enrolled

John Mark Gubatan, MDPrincipal InvestigatorStanford University

Media Library

Vitamin D (Vitamin Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04828031 — Phase 1

Inflammatory Bowel Disease Research Study Groups: Vitamin D 50,000 IU PO every week

Inflammatory Bowel Disease Clinical Trial 2023: Vitamin D Highlights & Side Effects. Trial Name: NCT04828031 — Phase 1

Vitamin D (Vitamin Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04828031 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI