UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032813 |
|---|---|
| Receipt number | 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 | 2020/12/02 18:54:52 |
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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
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
n-makabe@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Completed
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 | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037421
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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