UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006972 |
|---|---|
| Receipt number | R000008114 |
| Scientific Title | Effect of branched-chain amino acid-enriched beverage "Amino-Value [CONC.]" supplementation in patients with glucocorticoid-induced muscle atrophy |
| Date of disclosure of the study information | 2011/12/29 |
| Last modified on | 2011/12/28 12:54:35 |
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Basic information
Public title
Effect of branched-chain amino acid-enriched beverage "Amino-Value [CONC.]" supplementation in patients with glucocorticoid-induced muscle atrophy
Acronym
Effect of branched-chain amino acid supplementation in patients with glucocorticoid-induced muscle atrophy
Scientific Title
Effect of branched-chain amino acid-enriched beverage "Amino-Value [CONC.]" supplementation in patients with glucocorticoid-induced muscle atrophy
Scientific Title:Acronym
Effect of branched-chain amino acid supplementation in patients with glucocorticoid-induced muscle atrophy
Region
| Japan |
Condition
Condition
Rheumatic diseases
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effect of commercially available drink "Amino value conc" in patients with rheumatic diseases taking glucocorticoids. To explore the diagnostic and evaluation procedures for skeletal muscle atrophy in those patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of muscle mass and function using manual muscle test, bioimpedance, X-ray CT, and MRI imaging.
Key secondary outcomes
Performance Status, evaluation of daily living activity,squatting
Blood and urine biochemistry
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Aminovalue conc 2 bottles after each meal, everyday, for 3 months
Interventions/Control_2
Control
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patints who visit IMSUT Hospital
2. Patients who give a written informed consent
3. At the time of informed consent, patients take and will take prednisolone (>10mg/day) for at least consecutive 3 months.
Key exclusion criteria
Severe kidney dysfunction
Severe proteinuria
Severe diabetes
Hematopoietic disorders
Severe hepatic dysfunction
Congenital abnormality in amino acid metabolism
Severe heart diseases
Patients with artificial ventilation
patients with severe infection
patients who are recruited or was recruited (within 1 month) in other clinical trials
Pregnancy, breast-feeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Tanaka |
Organization
IMSUT Hospital, Institute of Medical Science, University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL
+81-3443-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noritada Yoshikawa |
Organization
IMSUT Hospital, Institute of Medical Science, University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo
TEL
+81-3443-8111
Homepage URL
hirotnk@ims.u-tokyo.ac.jp
Sponsor or person
Institute
IMSUT Hospital, Institute of Medical Science, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
東京大学医科学研究所附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 29 | 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
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008114
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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