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| Name | Class |
|---|---|
| Canadian Association of Gastroenterology | INDUSTRY |
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This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.
In patients with Crohn's disease in remission, the investigators hypothesized higher doses of vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be tolerated well without side effects of hypercalcemia. The investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety symptoms. In order to determine if there is benefit from high-dose vitamin D3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin D3 at 10,000 IU daily to 1000 IU daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Vitamin D3 (10,000 IU daily) | Active Comparator |
| |
| Low Dose Vitamin D3 (1000 IU daily) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in 25-OH vitamin D level | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission (defined as Harvey-Bradshaw index <=4) | Number of patients who maintain clinical remission | One year |
| Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS)) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27975236 | Derived | Narula N, Cooray M, Anglin R, Muqtadir Z, Narula A, Marshall JK. Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study. Dig Dis Sci. 2017 Feb;62(2):448-455. doi: 10.1007/s10620-016-4396-7. Epub 2016 Dec 14. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| 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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Number of patients who achieve significant improvement in HADS (reduction of 2 or more)
| One year |
| Improvement in C-reactive protein | Comparison of C-reactive protein levels in high and low dose vitamin D3 groups | One year |
| Adverse events | Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events | One year |
| D007410 | Intestinal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |