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Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamain D | This group of patients were supplemented with 125IU/d Vitamin D |
| |
| Control | The other group did not receive the supplementation of 125IU/d Vitamin D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caltrate Pill | Drug | VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25 (OH) D level | Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status. | 54 weeks |
| disease activity | CDAI evaluation | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the metabolism of calcium and phosphorus | serum levels calcium and phosphorus | 54 weeks |
| the expression profiles of Th-cell-related cytokines | Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-α and IFN-γ |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese
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| Name | Affiliation | Role |
|---|---|---|
| Xia sheng long long, Master | Second Affiliated Hospital of Wenzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SAHWenzhouMU | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34746207 | Derived | Xia SL, Min QJ, Shao XX, Lin DP, Ma GL, Wu H, Cao SG, Jiang Y. Influence of Vitamin D3 Supplementation on Infliximab Effectiveness in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study. Front Nutr. 2021 Oct 22;8:739285. doi: 10.3389/fnut.2021.739285. eCollection 2021. |
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Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| 54 weeks |
| D007410 | Intestinal Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |