UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040262 |
|---|---|
| Receipt number | R000045635 |
| Scientific Title | Seasonal variation of dehydration markers among community-dwelling elderly |
| Date of disclosure of the study information | 2020/04/28 |
| Last modified on | 2020/10/28 23:22:52 |
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Basic information
Public title
Seasonal variation of dehydration markers among community-dwelling elderly
Acronym
Seasonal variation of dehydration markers among community-dwelling elderly
Scientific Title
Seasonal variation of dehydration markers among community-dwelling elderly
Scientific Title:Acronym
Seasonal variation of dehydration markers among community-dwelling elderly
Region
| Japan |
Condition
Condition
Participants aged 65 years and above, who received annual health checkups
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate seasonal variations of dehydration markers in community-dwelling elderly
Basic objectives2
Others
Basic objectives -Others
To investigate seasonal variations of dehydration markers in community-dwelling elderly
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma osmolality
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants aged 65 years and above, who received annual health checkups at Nihon University Hospital from January 2019 to December 2019, were potentially eligible.
Key exclusion criteria
Exclusion criteria was estimated glomerular filtration rate (eGFR) <30 mL/ mL/min/1.73m2 and missing data of studied laboratory parameter.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Internal Medicine
Zip code
101-8309
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
TEL
03-3293-1711
fujishiro.midori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Tanaka |
Organization
Nihon University Hospital
Division name
Internal Medicine
Zip code
101-8309
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
TEL
03-3293-1711
Homepage URL
tanaka.sho@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nihon University Hospital IRB
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
Tel
03-3293-1711
tanaka.sho@nihon-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
| 2020 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/ggi.14010
Number of participants that the trial has enrolled
903
Results
The spring group showed the highest levels of plasma osmolality, urine specific gravity and prevalence rates of urine specific gravity exceeding 1.020. The summer group showed lower urine specific gravity levels and prevalence rates of urine specific gravity exceeding 1.020 than did the not summer group. The summer season was associated with low urine specific gravity levels even after adjusting for the multiple linear regression model.
Results date posted
| 2020 | Year | 10 | Month | 28 | Day |
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
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolled participants were classified into two groups according to the date of health checkup, that was Summer (June-August) and not-Summer (September-May) group. Additionally, not-Summer group was divided into three groups, that was Spring (March-May), Autumn (September-November) and Winter (December-February).
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045635
