UMIN-CTR Clinical Trial

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
Email	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
Email	tanaka.sho@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045635

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.