UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002155 |
|---|---|
| Receipt number | R000002633 |
| Scientific Title | Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy |
| Date of disclosure of the study information | 2009/07/06 |
| Last modified on | 2018/09/10 18:15:34 |
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Basic information
Public title
Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Acronym
Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Scientific Title
Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Scientific Title:Acronym
Effects of falecalcitoriol on post-operative hypoparathyroidism after thyroidectomy
Region
| Japan |
Condition
Condition
Postoperative hypoparathyroidism
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of falecalcitriol on hypocalcemia deu to hypoparathyroidism after thyroidectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Serum calcium level
Key secondary outcomes
Subjective Symptoms/Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose postoperative serum calcium levels are below lower limit deu to parathyroidectomy in thyroidectomy
Key exclusion criteria
1) Patients with an allergic history of falecalcitoriol
2) Patients who are judged as being unsuitable for the trial by the doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tanaka |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
tanakaka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tanaka |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
tanakaka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki medicak school
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School, Breast and Thyroid Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002633
