UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012424 |
|---|---|
| Receipt number | R000014543 |
| Scientific Title | Safety and efficacy of L-carnitine supplementation in patients with hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2013/11/27 |
| Last modified on | 2018/12/03 09:29:32 |
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Basic information
Public title
Safety and efficacy of L-carnitine supplementation in patients with hematopoietic stem cell transplantation
Acronym
L-carnitine supplementation for hematopoietic stem cell transplantation
Scientific Title
Safety and efficacy of L-carnitine supplementation in patients with hematopoietic stem cell transplantation
Scientific Title:Acronym
L-carnitine supplementation for hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Hematological malignancy, Bone marrow failure syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the safety and efficacy of L-carnitine supplementation in patients with stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in average fatigue from baseline to day100
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-carnitine supplementation
Interventions/Control_2
No carnitine supplementation
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included 20 years of age or older. All patients need possiblility of survival of more than 3 months from the time of registration and written informed consent.
Key exclusion criteria
Exclusion criteria included intake of carnitine in the last two months, carnitine allergy, severe complications, pregnancy, severe mental illness.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Iyama |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
Address
South-1 West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
iyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Iyama |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
Address
South-1 West-16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
iyama@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine, Department of Medical Oncology and Hematology
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine, Department of Medical Oncology and Hematology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | 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
| 2013 | Year | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014543
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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