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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035329
Receipt No. 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

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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
Last 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
Email mizuho@tiara.ocn.ne.jp

Public contact
1st 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
Email mizuho@tiara.ocn.ne.jp

Sponsor
Institute Mizuho hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040065

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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