UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035329 |
|---|---|
| Receipt number | R000040065 |
| Scientific Title | Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2018/12/20 22:35:19 |
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Basic information
Public title
Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients
Acronym
Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients
Scientific Title
Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients
Scientific Title:Acronym
Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether intake of medium-chain fatty acids may improve nutrition in dialysis patients suspected of PEW, we evaluated blood biochemistry, body composition, muscle mass and dietary intake of those admitted in our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood: parameters reflecting nutritional status before starting and after 12-months.
Key secondary outcomes
Dietary intake,Body composition,Comparison between nutritional status before starting and after 12-months.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Nine g/day of medium-chain fatty acids are added to diet
Added to the meal for 3 months from the start of the test until the 12th week, not added every 3 months thereafter, ending without addition or addition
Interventions/Control_2
Nine g/day of medium-chain fatty acids are added to diet
It is not added to the meal for 3 months from the start of the examination until the 12th week, not added and added every 3 months thereafter, ending with addition
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
long-term admitted patients who are capable of oral intake
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Kosiho |
Organization
Mizuho hospital
Division name
Internal medicine
Zip code
Address
422-1,katabata,tsubata-cho,kahoku-gun,Ishikawa,Japan
TEL
076-255-3008
mizuho@tiara.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Kakuno |
Organization
Mizuho hospital
Division name
Nutrition department
Zip code
Address
422-1,katabata,tsubata-cho,kahoku-gun,Ishikawa,Japan
TEL
076-255-3008
Homepage URL
mizuho@tiara.ocn.ne.jp
Sponsor or person
Institute
Mizuho hospital
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 04 | 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
| 2018 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | 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
| 2018 | Year | 12 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040065
