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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs041180126 |
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Date of registration:
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23/03/2019 |
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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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CD Alfacalcidol study
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Scientific title:
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The study of effect of Alfacalcidol treatment on Crohn's disease |
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Date of first enrolment:
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17/06/2017 |
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Target sample size:
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36 |
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Recruitment status: |
Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs041180126 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), no treatment control/standard of care control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Tsunaki
Sawada |
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Address:
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65-banchi, Tsurumai-cho, Showa-ku, Aichi
466-8560
Aichi
Japan |
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Telephone:
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+81-527442172 |
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Email:
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t.sawada@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya univesity hospital |
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Name:
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Masanao
Nakamura |
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Address:
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65-banchi, Tsurumai-cho, Showa-ku, Aichi
466-8560
Aichi
Japan |
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Telephone:
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+81-527442172 |
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Email:
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makamura@med.nagoya-u.ac.jp |
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Affiliation:
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Nagoya univesity hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Crohn's disease
CDAI less than 220
no steroids use
Exclusion criteria: patients with miled or severe active lesion in the colon
use of vitamin D supplement and medicine including Mg, Digitalis, PTH preparations, steroids, anti-tuberculosis drugs
pregnancy
Age minimum:
>= 18age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's disease
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Intervention(s)
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administration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level.
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Primary Outcome(s)
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Percentage of groups showing endoscopic improvement after 3 months administration of Alfacalcidol (response rate)
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Secondary Outcome(s)
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response rates after 3 month
endoscopic score, clinical score, clinical date, microbiota
relationship between endoscopic score and vitamin D
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date:
Contact:
ethics@med.nagoya-u.ac.jp
Nagoya University Certified Review Board
+81-52-744-2479
ethics@med.nagoya-u.ac.jp
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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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