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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (Cholecalciferol) | Dietary Supplement | 2000 IU of Vitamin D daily (1 pill) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samantha C Hess, BSc Honours | Contact | 226-377-4557 | sam.hess@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Terry Ponich, MD | Victoria Hospital - London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Hospital - London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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. | 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. | 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. | 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. | Enrollment until 12 month follow up |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |