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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038526
Receipt No. 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 2020/05/09

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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
Email 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
Email katokt@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 01 Day
Date of IRB
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
2020 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043908

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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