UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024044 |
|---|---|
| Receipt number | R000027689 |
| Scientific Title | Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward. |
| Date of disclosure of the study information | 2016/10/28 |
| Last modified on | 2016/09/14 01:26:55 |
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Basic information
Public title
Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Acronym
Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Scientific Title
Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Scientific Title:Acronym
Prospective study of BCAA-enriched supplement for older patients with hip fracture surgery in Kaifukuki Rehabilitation Ward.
Region
| Japan |
Condition
Condition
sarcopenia/hip fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Branched-Chain Amino Acid(BCAA)-enriched supplement on muscle mass and strength and ADL status in older patients with hip fracuture surgery in Kaifukuki Rehabilitation Ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass/muscle strength/ADL once every 2-4
weeks
1) Muscle mass(BIA method)
2) Muscle strength(hand grip, knee extension muscle strength)
3) ADL(FIM,10m walk test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily intake of BCAA-enriched supplement after rehabilitation
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
Postoperative hip fracture patients in Kaifukuki Rehabilitation Ward.
1) Patients with adequate oral intake
2) BMI<25
Key exclusion criteria
1) Patients with co-morbid disease which might affect evaluation of study, such as infectious disease.
2) Patients allergic to milk and soybeans.
3) Patients who are judged inappropriate for the study by the physician.
4) Patients with decreased renal function (eGFR<30)
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Miyata |
Organization
Research Institute for Radiation Biology and Medicine
Division name
surgical oncology
Zip code
Address
1-2-3, Kasumi, Minami-ku
TEL
082-257-5869
ymiyata@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keizo Misumi |
Organization
Research Institute for Radiation Biology and Medicine
Division name
surgical oncology
Zip code
Address
1-2-3, Kasumi, Minami-ku
TEL
082-257-5869
Homepage URL
misumik@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
Clinico Co., Ltd
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
| 2016 | Year | 10 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 28 | 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
| 2016 | Year | 09 | Month | 14 | Day |
Last modified on
| 2016 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027689
