UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032505 |
|---|---|
| Receipt number | R000037071 |
| Scientific Title | The effects of ingestion of citrulline -containing protein nutritional supplement on rehabilitation patients |
| Date of disclosure of the study information | 2018/05/08 |
| Last modified on | 2018/05/08 10:47:47 |
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Basic information
Public title
The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Acronym
The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Scientific Title
The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Scientific Title:Acronym
The effects of ingestion of citrulline -containing protein nutritional supplement on
rehabilitation patients
Region
| Japan |
Condition
Condition
stroke patients, femoral neck fracture patients, Vertebral compression fractures
Classification by specialty
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate whether the ingestion of citrulline-containing protein nutritional supplement in rehabilitation units patients could be effected with the physical performance, nutrition status and reactive oxygen species (ROS)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fim, functional independence measure
Key secondary outcomes
body composition, physical performance,nutritional status, blood flow, reactive oxygen species
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
protein nutritional supplement on rehabilitation patients for 28 days
Interventions/Control_2
citrulline (1 g)-containing protein nutritional supplement
on rehabilitation patients for 28 days
Interventions/Control_3
citrulline (3 g)-containing protein nutritional supplement
on rehabilitation patients for 28 days
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The stable condition rehabilitation patients with stroke, femoral neck fracture and vertebral compression fractures
Key exclusion criteria
acute heart failure, chronic kidney disease,liver failure
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuya Yamauchi |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Division of Rehabilitation
Zip code
Address
1-20-1 Handayama Higashiku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2747
yamakatu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Yamauchi |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Division of Rehabilitation
Zip code
Address
1-20-1 Handayama Higashiku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2747
Homepage URL
yamakatu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, University Hospital Division of Rehabilitation
Enshyu Hospital Division of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Otsuka phamaceutical factory
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 05 | Month | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037071
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
