UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006555 |
|---|---|
| Receipt number | R000007767 |
| Scientific Title | Randomized study of elemental diet supplemented nutrition for stem cell transplantation. |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2023/10/27 20:33:38 |
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Basic information
Public title
Randomized study of elemental diet supplemented nutrition for stem cell transplantation.
Acronym
Elemental diet for stem cell transplantation
Scientific Title
Randomized study of elemental diet supplemented nutrition for stem cell transplantation.
Scientific Title:Acronym
Elemental diet for stem cell transplantation
Region
| Japan |
Condition
Condition
stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the role of elemental diet on clinical outcomes after stem cell transplanation, we conducted a double-blind
randomized study comparing patients who received elemental diet supplemented nutrition with patients who received standard nutrition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mucositis oral, grade 2 to 4
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
A dose of 80g/body of elementa diet, was added to patients during the 40 days, that is, from the day before 10 days of start of conditioning to the 30th day after stem cell transplantation.
Interventions/Control_2
standard nutritional support
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
The patient who planned stem cell transplantation
Key exclusion criteria
Patients with renal failure, cirrhosis, congestive heart failure, nephrotic syndrome or other diseases that interfered with the absorption and flux of water and solutes
were also excluded. Patient with pregnancy were also excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Iyama |
Organization
Sapporo medical university
Division name
4th internal medicine
Zip code
0608543
Address
South-1 West-17, Chuo-ku, Sapporo, Japan.
TEL
011-611-2111
iyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Iyama |
Organization
Sapporo medical universty
Division name
4th internal medicine
Zip code
0608543
Address
South-1 West-16, Chuo-ku, Sapporo, Japan
TEL
81-11-611-2111
Homepage URL
iyama@sapmed.ac.jp
Sponsor or person
Institute
4th internal medicine, Sapporo medical university
Institute
Department
Personal name
Funding Source
Organization
4th internal medicine, Sapporo medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
S-1, W-16, Chuo-ku, Sapporo, Hokkaido, JAPAN
Tel
011-611-2111
iyama@sapmed.ac.jp
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
| 2011 | Year | 11 | Month | 01 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007767
| 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 |
