UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of L-carnitine supplementation in patients with hematopoietic stem cell transplantation
Title of the study (Brief title)	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	Satoshi Iyama
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology and Hematology
Address	South-1 West-16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Email	iyama@sapmed.ac.jp

Public contact
Name of contact person	Satoshi Iyama
Organization	Sapporo Medical University School of Medicine
Division name	Department of Medical Oncology and Hematology
Address	South-1 West-16, Chuo-ku, Sapporo, Japan
TEL	011-611-2111
Homepage URL
Email	iyama@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine, Department of Medical Oncology and Hematology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014543