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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.
Register: JPRN
Last refreshed on: 17 October 2023
Main ID:  JPRN-UMIN000025961
Date of registration: 01/03/2017
Prospective Registration: Yes
Primary sponsor: Nagoya University Hospital
Public title: The study of effect of Alfacalcidol treatment on Crohn's disease
Scientific title: The study of effect of Alfacalcidol treatment on Crohn's disease - The study of effect of Alfacalcidol treatment on Crohn's disease
Date of first enrolment: 2017/05/21
Target sample size: 31
Recruitment status: Recruiting
URL:  https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029845
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Tsunaki    Sawada
Address:  65 Tsurumai, Shouwa, Nagoya-City, Aichi 466-8560 Japan
Telephone: 0527442172
Email: t.sawada@med.nagoya-u.ac.jp
Affiliation:  Nagoya University Hospital Department of Gastroenterology and Hepatology
Name: Masanao    Nakamura
Address:  65 Tsurumai, Shouwa, Nagoya-City, Aichi Japan
Telephone: 0527442172
Email: osa-wata@med.nagoya-u.ac.jp
Affiliation:  Nagoya University Hospital Department of Gastroenterology and Hepatology
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: Patient who has moderate to severe colitis Hypercalcemia Patient who is taking Calcium formulation,Vitamin D and Vitamin D analog Patient who is taking medicine including magnesium, digitalis, PTH formulation. Expectant and nursing mothers

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Oral treatment of Alfacalcidol 1 microgram/day for 3 month
Primary Outcome(s)
Improvement rate on endoscopic score after 3 month.
Secondary Outcome(s)
Improvement rate on clinical score comparison of endoscopic score, clinical score, biomarker between before and after treatment
Secondary ID(s)
Source(s) of Monetary Support
Nagoya University Graduate School of Medicine
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 21/05/2017
Contact:
ethics@med.nagoya-u.ac.jp
Nagoya University Certified Review Board
052-744-2479
ethics@med.nagoya-u.ac.jp
Results
Results available: Yes
Date Posted:
Date Completed: 31/03/2020
URL:
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