NCT07177157Active, not recruitingPhase 1
The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients
The Prospective Improved Vitamin D Study for IBD Patients Part 2 (The PIVD Study Part 2)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 29 Aug 2025
- Start date
- 5 Nov 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Terry Ponich
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07177157
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 5 Nov 2025 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those with a history of vitamin D supplementation within 6 months prior to the trial.
Other illness
- Those with advanced liver disease (Note: individuals with mild liver disease may be included at the physician's discretion).
- Those using continuous oral corticosteroids for the management of any disease other than IBD.
Lab values
- Those with any concurrent diagnosis of a disease that may affect calcium or vitamin D metabolism (i.e., thyroid disease, parathyroid disease, primary bone disease, granulomatous disease, sarcoidosis, lymphoma).
- Those with renal dysfunction (serum creatinine \>0.150 mmol/L), those receiving dialysis, or those with hypercalcemia (\>2.65 mmol/L).
Other
- Those who do not meet the inclusion criteria.
- Those who are unable to attend follow-up appointments with the gastroenterology team.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Victoria Hospital, London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.