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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045635