UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of medium-chain fatty acids intake on serum albumin concentration and body composition in dialysis patients
Title of the study (Brief title)	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	Yoshitaka Kosiho
Organization	Mizuho hospital
Division name	Internal medicine
Address	422-1,katabata,tsubata-cho,kahoku-gun,Ishikawa,Japan
TEL	076-255-3008
Email	mizuho@tiara.ocn.ne.jp

Public contact
Name of contact person	Ai Kakuno
Organization	Mizuho hospital
Division name	Nutrition department
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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