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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-UMIN000002155 |
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Date of registration:
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06/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
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Scientific title:
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Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy - Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy |
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Date of first enrolment:
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2009/09/01 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002633 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Katsuhiro Tanaka |
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Address:
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577,Matsushima, Kurashiki, Okayama 701-0192, Japan
Japan |
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Telephone:
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086-462-1111 |
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Email:
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tanakaka@med.kawasaki-m.ac.jp |
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Affiliation:
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Kawasaki Medical School Breast and Thyroid Surgery |
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Name:
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Katsuhiro Tanaka |
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Address:
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577,Matsushima, Kurashiki, Okayama 701-0192, Japan
Japan |
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Telephone:
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086-462-1111 |
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Email:
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tanakaka@med.kawasaki-m.ac.jp |
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Affiliation:
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Kawasaki Medical School Breast and Thyroid Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients with an allergic history of falecalcitoriol 2) Patients who are judged as being unsuitable for the trial by the doctor
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Postoperative hypoparathyroidism
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Intervention(s)
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In the first day after operation, we start administration of falecalcitriol at a dosage of 0.6ug once a day, when below the lower limit of serum calcium. If serum calcium level do not reach normal range, we escalete to 0.9ug/day.Oral calcium lactate is administered 3g/day in all enrolled patients.The dose is reduced when serum calcium and intact PTH level are maintained within normal range. If subjective symptoms such as tetany are worsen up, we start administration of calcium via DIV.
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Primary Outcome(s)
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Serum calcium level
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Secondary Outcome(s)
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Subjective Symptoms/Safety
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Source(s) of Monetary Support
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Kawasaki Medical School, Breast and Thyroid Surgery
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/08/2018 |
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URL:
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