UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039878 |
|---|---|
| Receipt number | R000045476 |
| Scientific Title | Thyoid nutrient system study |
| Date of disclosure of the study information | 2020/03/19 |
| Last modified on | 2021/02/18 08:24:10 |
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Basic information
Public title
Thyoid nutrient system study
Acronym
Thyoid nutrient system study
Scientific Title
Thyoid nutrient system study
Scientific Title:Acronym
Thyroid-V study
Region
| Japan |
Condition
Condition
hyperthyroidism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of hyperthyroid state on nutritional dynamics in the body.
Basic objectives2
Others
Basic objectives -Others
To investigate the dynamics of vitamins amino acids related to body composition with and without thyrotoxicosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of thyrotoxicosis before and 3 months after treatment for thyrotoxicosis
Key secondary outcomes
Presence of thyrotoxicosis before and 1 months after treatment for thyrotoxicosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with thyrotoxicosis (Graves' disease, destructive thyroiditis)
2. Patients with recurrent thyrotoxicosis
Key exclusion criteria
(1) Patients who have fasted for 3 days or more due to poor appetite at the time of registration, or are undergoing enteral or tube feeding
(2) Pregnant and dialysis patients at the time of registration
(3) Patients who are using over-the-counter supplements and vitamins within one month before registration
(4) Other patients judged by the researcher to be inappropriate as study subjects
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Saito |
Organization
Shizuoka Prefectual Hospital Organization
Division name
Department of Endocrinology and Diabetes
Zip code
420-8527
Address
4-27-1 Kita-ando, Aoi-ku, Shizuoka-City 420-9527, JAPAN
TEL
0542476111
kohei-saito@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Saito |
Organization
Shizuoka Prefectual Hospital Organization
Division name
Department of Endocrinology and Diabetes
Zip code
420-8527
Address
4-27-1 Kita-ando, Aoi-ku, Shizuoka-City 420-9527, JAPAN
TEL
0542476111
Homepage URL
kohei-saito@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka Prefectual Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefectual Hospital Organization
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
Shizuoka Prefectual Hospital Organization
Address
Research Support Office
Tel
0542476111
chiken-sougou@shizuoka-pho.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
| 2020 | Year | 03 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single Arm comparison test
To comprehensively measure serum vitamin and amino acid concentrations in patients with hyperthyroidism, and search for clinically significant measurement items.
This study is a preliminary study for future translational clinical research
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045476
