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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032813
Receipt No. R000037421
Scientific Title The development of nutrition therapy for latter-stage elderly to maintain and improve ADL: multicenter alternative study
Date of disclosure of the study information 2018/06/01
Last modified on 2020/06/05

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Basic information
Public title The development of nutrition therapy for latter-stage elderly to maintain and improve ADL: multicenter alternative study
Acronym The development of nutrition therapy for latter-stage elderly to maintain and improve ADL
Scientific Title The development of nutrition therapy for latter-stage elderly to maintain and improve ADL: multicenter alternative study
Scientific Title:Acronym The development of nutrition therapy for latter-stage elderly to maintain and improve ADL
Region
Japan

Condition
Condition fracture, pneumonia, urinary tract infection, cancer
Classification by specialty
Geriatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to develop the effective and practical method of nutrition treatment which paid attention to ADL maintenance/improvement for latter-stage elderly with lifestyle diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of the activity of daily living, skeletal muscle mass, muscle strength
Key secondary outcomes Changes of dietary intakes (energy, protein, vitamin D, etc.), hemoglobin, aspartate aminotransferase, alanine aminotransferase, creatinine, blood urea nitrogen, estimated glomerular filtration rate, serum albumin, c-reactive protein.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intensive nutrition (energy 25-35 kcal/kgBW, protein 1.5 g/kgBW, vitamin D 10 microg)
Interventions/Control_2 Conventional nutrition (energy 25-35 kcal/kgBW, protein 1.0 g/kgBW)
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)75 years old at the first date of hospitalization
(2) Patients with fracture, pneumonia, urinary tract infection, cancer
(3) Nursing necessary degree of B is less than three points during hospitalization
(4) MNA-Short Form is 8 to 11 points
Key exclusion criteria (1) Dementia or mental disease
(2) Using steroid
(3) Severe liver and/or renal dysfunction (Child-Pugh classification > 7, Cre > 2 mg/dL)
(4) Heart failure (New York Heart Association class 2, 3, 4)
(5) Severe diabetic complications (nephropathy; stage 3-4, proliferative retinopathy, neuropathy)
(6) Patients with SIRS or AIS score > 4
(7) Patients with the past of the gastrointestinal operation
(8) Cancer which cannot cure radically
(9) Patients with a pacemaker or the shrubbery model defibrillator
(10) Patients who have motor paralysis in their limbs due to neuromuscular disease
(11) Patient who judged that a study enforcement person in charge or a study partaker was unsuitable for this clinical study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Seino
Organization Kansai Electric Power Hospital
Division name President
Zip code 553-0003
Address 2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL 06-6458-5821
Email yutaka.seino.hp@gmail.com

Public contact
Name of contact person
1st name Noboru
Middle name
Last name Makabe
Organization Kansai Electric Power Hospital
Division name The AMED Seino squad secretariat
Zip code 553-0003
Address 2-1-7 Fukushima, Fukushima Ward, Osaka 5530003, Japan.
TEL 06-6458-5821
Homepage URL
Email n-makabe@umin.ac.jp

Sponsor
Institute Kansai Electric Power Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Society of Metabolism and Clinical Nutrition
Address 3-13-11 Yotsuya, Shinjuku-ku, Tokyo Sakae Building 5F
Tel 03-5363-2361
Email jimukyoku@eiyou.or.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
2018 Year 06 Month 01 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 200
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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 15 Day
Date of IRB
2018 Year 05 Month 31 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded
2020 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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