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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT04606017 |
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Date of registration:
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25/10/2020 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease
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Scientific title:
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Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study |
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Date of first enrolment:
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January 1, 2014 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04606017 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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China
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Contacts
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Name:
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Xia sheng long long, Master |
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Address:
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Telephone:
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Email:
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Affiliation:
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Second Affiliated Hospital of Wenzhou Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- moderate-to-severe CD
- Treated with Infliximab
- bio-naïve at the time of diagnosis
Exclusion Criteria:
- had recent supplementation of vitD3
- had prior or concomitant use of other biologic agent, glucocorticoid and/or
immunomodulators at the time of enrollment
- pregnant
- had cognitive/developmental disorders that affected their ability to complete the
study procedures
- had medical illness or therapies potentially affecting bone, nutrition or growth
status
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin D Deficiency
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Vitamin D Supplement
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Crohn Disease
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Intervention(s)
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Drug: Caltrate Pill
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Primary Outcome(s)
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Serum 25 (OH) D level
[Time Frame: 54 weeks]
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disease activity
[Time Frame: 54 weeks]
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Secondary Outcome(s)
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the expression profiles of Th-cell-related cytokines
[Time Frame: 54 weeks]
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the metabolism of calcium and phosphorus
[Time Frame: 54 weeks]
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Secondary ID(s)
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SAHoWMU-CR2020-01-213
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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