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| Name | Class |
|---|---|
| Dania Alrefai | UNKNOWN |
| Dr.Jennifer Jones | UNKNOWN |
| Dr.Hani Jawa | UNKNOWN |
| Dr.Wael El-matary |
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The purpose for this study is to determine the effect of vitamin D supplementation on disease activity in Crohn's disease patients in Canada and Saudi Arabia
Hypothesis 1: Patients who are suffering from Crohn's disease are at risk of vitamin D deficiency.
To determine vitamin D status and disease activity in Crohn's disease cases in Canada and Saudi Arabia.
Hypothesis 2: Providing vitamin D in doses higher than RDA (Recommended Dietary Allowance) reduces disease activity in Crohn's disease cases.
To evaluate the impact vitamin D in doses higher than RDA (Recommended Dietary Allowance) on disease activity in Crohn's disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 3 | Experimental | Vitamin D3, 10,000 IU daily |
|
| Group 2 | Experimental | Vitamin D3 2,000 IU daily |
|
| Group 1 | Experimental | Vitamin D3 600 IU daily (Control group, RDA level) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes in disease activity on groups | We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) To measure the disease activity, we will examine C- reactive protein levels "blood test", Fecal fat " stool test" and Crohn's disease activity index (CDAI)"tool". | (0), 5 weeks, 9 weeks, after 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| nutritional status | We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up). We will use 24-hour dietary recalls for 9 different days. | 0, 5 weeks, 9 weeks, 2 months later |
| vitamin D status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassanali Vatanparast, MD,PhD | University of Saskatchewan, Saskatoon, SK,Canada | Principal Investigator |
| Jennifer Jones, MD,MSc,FRCPC | Royal University Hospital, Saskatoon, Saskatchewan, Canada | Study Director |
| Hani Jawa, MBBS,ABIM,FRCPC | King Abdulaziz University, jeddah, Saudi Arabia | Study Director |
| Wael El-matary, MBChB,MSc,MD,FRCPCH | University of Manitoba | Study Director |
| Dania Alrefai, M.Sc | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBD clinic; Royal University Hospital | Saskatoon | Saskatchewan | Canada | |||
| Internal Medicine Department; King Abdulaziz University Hospital |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| 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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| Saudi Arabian Cultural Bureau | UNKNOWN |
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We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up) vitamin D status: Blood test
| (0), Week 5, Week 9 (termination) and 2 months later |
| Health related quality of life | We have 4 time points, baseline (0), Week 5, Week 9 (termination) and Week 17 (follow up). We will use Health related quality of life questionnaire. | (0), Week 5, Week 9 (termination) and 2 months later (follow up) |
| Jeddah |
| Saudi Arabia |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |