UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038526 |
|---|---|
| Receipt number | R000043908 |
| Scientific Title | The role of nutritional intervention by dietitians for low iodine diet in radioiodine therapy for Graves' hyperthyroidism |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2023/05/12 13:22:38 |
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Basic information
Public title
The role of nutritional intervention by dietitians for low iodine diet in radioiodine therapy for Graves' hyperthyroidism
Acronym
The role of nutritional intervention by dietitians for low iodine diet in radioiodine therapy for Graves' hyperthyroidism
Scientific Title
The role of nutritional intervention by dietitians for low iodine diet in radioiodine therapy for Graves' hyperthyroidism
Scientific Title:Acronym
The role of nutritional intervention by dietitians for low iodine diet in radioiodine therapy for Graves' hyperthyroidism
Region
| Japan |
Condition
Condition
Graves' hyperthyroidism
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine whether 1-2 weeks of low iodine diet was appropriate in patients who were planned to receive radioactive iodine I-131 therapy for Graves' hyperthyroidism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effect of radioactive iodine I-131 therapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Instruction of low iodine diet by Radiologist or nutritionist
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to receive radioactive iodine I-131 therapy for Graves' hyperthyroidism.
Key exclusion criteria
Patient underage
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
461-8673
Address
1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan
TEL
052-719-1590
katokt@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Radiological and Medical Laboratory Sciences
Zip code
461-8673
Address
1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan
TEL
052-719-1590
Homepage URL
katokt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
1-20, Daikominami 1-chome, Higashi-ku, Nagoya, Japan
Tel
052-719-1590
katokt@med.nagoya-u.ac.jp
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
| 2019 | Year | 11 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043908
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
