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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000040262 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Participants aged 65 years and above, who received annual health checkups | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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 |
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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 |
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Results Delayed | |||||||
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Baseline Characteristics | |||||||
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |