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Clinical Trials in Canada / NCT07177157
Starting soon Phase 1

The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients

NCT07177157 · tracked via the Priya Life Science Canada tracker
Sponsor
Terry Ponich
Phase
Phase 1
Started
2025-10
Last updated
2025-09-16

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Vitamin D3 (Cholecalciferol)

Vitamin D3 (Cholecalciferol): 2000 IU of Vitamin D daily (1 pill)

Study 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:

1. What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period?
2. Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients?
3. Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period?
4. Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period?
5. Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients?
6. Is 2,000 IU/Day an effective dose to sustain appropriate blood Vitamin D levels among previously Vitamin deficient IBD patients?

Participants will:

* 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adults Aged 18-85 2. Diagnosis of IBD (Ulcerative Colitis or Crohn's Disease) within the patient's records based on standard clinical, endoscopic, and radiologic criteria. 3. 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). 4. Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance. Exclusion Criteria: 1. Those who do not meet the inclusion criteria. 2. 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). 3. 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). 4. Those using oral corticosteroids for the management of any disease other than IBD. 5. Those with a history of Vitamin D or calcium supplementation within 6 months prior to the trial. 6. Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Victoria Hospital - London Health Sciences Centre London Ontario

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07177157 on ClinicalTrials.gov ↗ ← All trials in Canada