Ulcerative Colitis (UC)Phase 1PIVDNCT07177157
The Prospective Improved Vitamin D Study for Inflammatory Bowel Disease Patients
A Phase 1 study testing Vitamin D3 (Cholecalciferol) in people with Ulcerative Colitis (UC) and IBD (Inflammatory Bowel Disease), run by Terry Ponich at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis (UC), IBD (Inflammatory Bowel Disease), Crohn Disease (CD)
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2025to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who do not meet the inclusion criteria.
- 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).
- 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.
- Those with a history of vitamin D supplementation within 6 months prior to the trial.
- Those who are unable to attend follow-up appointments with the gastroenterology team.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Victoria Hospital - London Health Sciences Centre
London, Ontario, N6A 5A5
About this study
Official title: The Prospective Improved Vitamin D Study for IBD Patients Part 2 (The PIVD Study Part 2)
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:
- What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period?
- Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients?
- Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period?
- Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period?
- Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients?
- Is 2,000 IU/Day an effective dose to sustain appropriate blood Vitamin D levels among previously Vitamin deficient IBD patients?
Read more
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
Read the detailed description
Upon investigating the literature, despite there being a lot of medication compliance research, there was not much research catered to IBD patient medication management specifically.
Vitamin D supplementation based on immune-modulatory effects alongside its beneficial effects on bone health can lead to reduced rates of osteopenia and osteoporosis in the IBD population. In the treatment of IBD, the major patient care objectives to relieve symptoms and reduce inflammation doesn't leave much time or consideration for other aspects of patient care such as Vitamin D supplementation.
This study will investigate the gastroenterology department at LHSC to assess the current state of adherence and monitoring of Vitamin D and other medications for both Crohn's disease and ulcerative colitis patients. This will be done through a prospective cohort study of patients whose records have stated that they are not currently on Vitamin D. Through assessing overall adherence, foundational understanding of the IBD population will be obtained and the use the ASK-12 questionnaire will be validated. Once done, this would allow for a broader understanding of the patient specific factors affecting individual adherence and lay the foundation for research into ways at increasing adherence among non-adherent individuals.
The overall objective of this study is to estimate the proportion of patients that adhere to Vitamin D supplements. It is the hope that through investigations Vitamin D monitoring and adherence can be standardized at LHSC and long term osteoporosis and osteopenia complications commonly experienced by the IBD patient population can be prevented.
The central hypothesis is that Vitamin D adherence among IBD patients is low and that it is closely related to the patient's IBD disease severity. It is anticipated for this Vitamin D trend to be reversed, as patients may want to stabilize the disease condition and limit acute exacerbations prior to restarting maintenance therapy in the form of Vitamin D treatment.
A clinician as part of the gastroenterology team at Victoria Hospital or St. Joseph's Hospital (Dr. Ponich and other members of VH GI team) who is the primary healthcare contact for the recruited patient will make initial contact with potential participants. Dr. Ponich or another member of the VH GI team will approach the patient in clinic after their visit and ask a member of the research team to discuss the purpose and procedure of the study. The research team member will have the patients fill out a short-written consent form that meets the standards at LHSCRI as submitted in the WREM application. The research team member will obtain written consent from the patient.
Recruited patient's will be provided Vitamin D supplementation and be asked to take 2,000 IU/day. No additional reinforcement will be provided to these patients. At both 6- and 12-month intervals, remaining supplements will be collected, and overall adherence will be assessed. Participants will be asked to complete the EQ-5D-5L to assess their health-related quality of life and the ASK-12 Questionnaire, which will be compared to the pill counts, to determine the validity of ASK-12 among IBD patients. The Patients' IBD will be assessed by performing either a Partial Mayo or CDAI Score as well as completing a fecal calprotectin test. Additionally, participant serum Vitamin D levels will be collected to determine whether adherence to medication resulted in an identifiable increase.
- Being tested
- Vitamin D3 (Cholecalciferol)
- Keywords
- vitamin D, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, Bone Health, Immune Modulation, Crohn Disease (CD)
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Dietary supplement
2000 IU of Vitamin D daily (1 pill)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin D3 (Cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to 12 month follow up
Secondary outcomes (5)
Validity of ASK-12 Survey
Determining the validity of the ASK-12 survey, a 12-item Short Health Survey adherence tool will be used to assess adherence rates, among the IBD patients. The ASK-12 Questionnaire detects patient specific barriers to medication adherence, with scores ranging from 12-60 (higher scores indicating a greater non-adherence). The ASK-12 also contains 3 separate subscales: (1) Adherence Behaviors, (2) Health Beliefs, (3) Inconvenience/Forgetfulness.
Measured: Enrollment until 12 month follow up
Quality of Life Assessment
Assessing the change in quality-of-life among IBD patient's using the EQ-5D-5L survey to assess the general health among the patient population. The EQ-5D-5L Health Survey is a 5- item survey that assesses both physical and mental health. There are 5 subcategories that consist of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. There is also a scale where the patient assesses their current overall health ranging from 0 (the worst health they can imagine) to 100 (the best health they can imagine). This tool will be used to compare any changes in health-related quality of life among IBD patients based on their individual rates to supplementations.
Measured: Enrollment until 12 month follow up
Crohn's Disease - Disease Severity
Assessing the patient's Crohn's Disease severity using the Crohn's disease activity index (CDAI) respectively. The CDAI is a validated tool in assessing disease severity among Crohn's disease patients, with a score >150 indicative of active disease. Any other scores would indicate that the disease is in remission. It will also be looked at by testing fecal calprotectin levels which will allow for comparison of the level of inflammation.
Measured: Enrollment until 12 -month follow up
Ulcerative Colitis - Disease Severity
Assessing the patient's Ulcerative Colitis disease severity using the Mayo Disease Activity Index (DAI) respectively. The DAI is a validated tool used in assessing disease severity among Ulcerative Colitis patients, with a score >2 indicative of active disease. Any other scores would indicate that the disease is in remission. It will also be looked at by testing fecal calprotectin levels which will allow for comparison of the level of inflammation.
Measured: Enrollment until 12-month follow up
Impact on Serum Vitamin D Levels
Assessing the effect that providing 2,000 IU/Day of Vitamin D supplements would have on the Serum Vitamin D of IBD patients. Serum Vitamin D levels will be collected and compared to the patient's individual adherence levels using the pill-counting method.
Measured: Enrollment until 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start5 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terry Ponich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry Ponich, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Terry P Ponich, MD, FRCPC, Principal investigator, Victoria Hospital - London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177157
- Sponsor's protocol ID
- WREM: 125544
- Acronym
- PIVD
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Improved Vitamin D Study for IBD Patients Part 2 (The PIVD Study Part 2)
- ClinicalTrials.gov ID
- NCT07177157
- Acronym / sponsor ID
- PIVD / WREM: 125544
- Keywords
- vitamin D, Inflammatory Bowel Disease, IBD, Ulcerative Colitis, Bone Health, Immune Modulation, Crohn Disease (CD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Terry PonichUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period?
- Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients?
- Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period?
- Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period?
- Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients?
- 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
Detailed description
Upon investigating the literature, despite there being a lot of medication compliance research, there was not much research catered to IBD patient medication management specifically.
Vitamin D supplementation based on immune-modulatory effects alongside its beneficial effects on bone health can lead to reduced rates of osteopenia and osteoporosis in the IBD population. In the treatment of IBD, the major patient care objectives to relieve symptoms and reduce inflammation doesn't leave much time or consideration for other aspects of patient care such as Vitamin D supplementation.
This study will investigate the gastroenterology department at LHSC to assess the current state of adherence and monitoring of Vitamin D and other medications for both Crohn's disease and ulcerative colitis patients. This will be done through a prospective cohort study of patients whose records have stated that they are not currently on Vitamin D. Through assessing overall adherence, foundational understanding of the IBD population will be obtained and the use the ASK-12 questionnaire will be validated. Once done, this would allow for a broader understanding of the patient specific factors affecting individual adherence and lay the foundation for research into ways at increasing adherence among non-adherent individuals.
The overall objective of this study is to estimate the proportion of patients that adhere to Vitamin D supplements. It is the hope that through investigations Vitamin D monitoring and adherence can be standardized at LHSC and long term osteoporosis and osteopenia complications commonly experienced by the IBD patient population can be prevented.
The central hypothesis is that Vitamin D adherence among IBD patients is low and that it is closely related to the patient's IBD disease severity. It is anticipated for this Vitamin D trend to be reversed, as patients may want to stabilize the disease condition and limit acute exacerbations prior to restarting maintenance therapy in the form of Vitamin D treatment.
A clinician as part of the gastroenterology team at Victoria Hospital or St. Joseph's Hospital (Dr. Ponich and other members of VH GI team) who is the primary healthcare contact for the recruited patient will make initial contact with potential participants. Dr. Ponich or another member of the VH GI team will approach the patient in clinic after their visit and ask a member of the research team to discuss the purpose and procedure of the study. The research team member will have the patients fill out a short-written consent form that meets the standards at LHSCRI as submitted in the WREM application. The research team member will obtain written consent from the patient.
Recruited patient's will be provided Vitamin D supplementation and be asked to take 2,000 IU/day. No additional reinforcement will be provided to these patients. At both 6- and 12-month intervals, remaining supplements will be collected, and overall adherence will be assessed. Participants will be asked to complete the EQ-5D-5L to assess their health-related quality of life and the ASK-12 Questionnaire, which will be compared to the pill counts, to determine the validity of ASK-12 among IBD patients. The Patients' IBD will be assessed by performing either a Partial Mayo or CDAI Score as well as completing a fecal calprotectin test. Additionally, participant serum Vitamin D levels will be collected to determine whether adherence to medication resulted in an identifiable increase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D3 (Cholecalciferol)Participants who have IBD (UC or CD) will receive Vitamin D3 and will take a 2000 IU pill daily for 12 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Those who do not meet the inclusion criteria.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (Cholecalciferol)2000 IU of Vitamin D daily (1 pill) | Dietary supplement | Vitamin D |
Primary outcome
Medication Adherence
Time frame: Enrollment to 12 month follow up
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.
5 secondary outcomes
Validity of ASK-12 Survey
Time frame: Enrollment until 12 month follow up
Quality of Life Assessment
Time frame: Enrollment until 12 month follow up
Crohn's Disease - Disease Severity
Time frame: Enrollment until 12 -month follow up
Ulcerative Colitis - Disease Severity
Time frame: Enrollment until 12-month follow up
Impact on Serum Vitamin D Levels
Time frame: Enrollment until 12 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry P Ponich, MD, FRCPC principal investigator
Victoria Hospital - London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 (Cholecalciferol) in people with Ulcerative Colitis (UC) and IBD (Inflammatory Bowel Disease), run by Terry Ponich at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Enrollment to 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.