The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTerry Ponich
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Those who do not meet the inclusion criteria.
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.
Trial design
Treatments tested in this trial
- Vitamin D3 (Cholecalciferol)
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Terry Ponich
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor institution
Source ClinicalTrials.gov