The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients

NCT07177157 | Not Yet Recruiting Phase 1

• 1 other identifier: WREM: 125544
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to gain a better understanding of the effect of Vitamin D supplementation on disease activity and overall health. The main questions it aims to answer are:

• Take 2000 IU of Vitamin D every day for the next 12 months
• Complete 2 surveys, bloodwork and a fecal calprotectin test at the initial, visit, 6 month follow up and 12 month follow up

Conditions

Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease); Crohn Disease (CD)

Keywords

vitamin D; Inflammatory Bowel Disease; IBD; Ulcerative Colitis; Bone Health; Immune Modulation; Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  Assessing the proportion of IBD patients, at both 6 and 12 months, who are adherent to Vitamin D supplementation using pill-counting of supplements provided to them.

  Enrollment to 12 month follow up

Secondary Outcomes (5)

• Validity of ASK-12 Survey

  Enrollment until 12 month follow up

• Quality of Life Assessment

  Enrollment until 12 month follow up

• Crohn's Disease - Disease Severity

  Enrollment until 12 -month follow up

• Ulcerative Colitis - Disease Severity

  Enrollment until 12-month follow up

• Impact on Serum Vitamin D Levels

  Enrollment until 12 month follow up

Study Arms (1)

Vitamin D

EXPERIMENTAL

Participants who have IBD (UC or CD) will receive Vitamin D3 and will take a 2000 IU pill daily for 12 months.

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Interventions

Vitamin D3 (Cholecalciferol) DIETARY_SUPPLEMENT

2000 IU of Vitamin D daily (1 pill)

Vitamin D

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults Aged 18-85
• Diagnosis of IBD (Ulcerative Colitis or Crohn's Disease) within the patient's records based on standard clinical, endoscopic, and radiologic criteria.
• Patients within outpatient gastroenterology clinics at Victoria Hospital and St. Joseph's Hospital with follow-up appointments within the next 2 years (ongoing IBD care).
• Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance.

You may not qualify if:

• Those with any concurrent diagnosis of disease that may affect calcium or Vitamin D metabolism (i.e., rheumatoid arthritis or other inflammatory joint disease, thyroid disease, parathyroid disease, primary bone disease, granulomatous disease, sarcoidosis, lymphoma).
• Those with either renal dysfunction (serum creatinine \>0.150 mmol/L) or receiving dialysis were excluded, patients with chronic liver disease, and hypercalcemia (\>2.65mmol/L).
• Those using oral corticosteroids for the management of any disease other than IBD.
• Those with a history of Vitamin D or calcium supplementation within 6 months prior to the trial.
• Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care).

Sponsors & Collaborators

• Terry Ponich: lead

Study Sites (1)

Victoria Hospital - London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Terry Ponich, MD

  Victoria Hospital - London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha C Hess, BSc Honours

CONTACT

226-377-4557; sam.hess@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterology Team Clinician - Victoria Hospital (LHSC)

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CA (1)