UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Title of the study (Brief title)	Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Region	Japan

Condition
Condition	CKD/ESRD
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Advanced-stage renal disease patients have potassium restriction on their diet. Therefore, low-potassium lettuce which can be consumed raw by these patients has been developed. The low-potassium lettuce made possible by novel cultivation method is likely safe for end-stage renal disease patients including those on dialysis. Moreover, the low-potassium lettuce maintains the nutritional value for elements other than potassium. Therefore, the consumption of low-potassium lettuce may inhibit the advancement of atherosclerosis and renal function deterioration. However, clinical evidence is still lacking. The aim of this clinical study is to examine the safety and efficacy of low-potassium lettuce.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum potassium
Key secondary outcomes	Total protein, albumin, blood urea nitrogen, creatinine, sodium, chloride, calcium, phosphate, magnesium, zinc, vitamin A, B1, B2, C, E, high-sensitivity C-reactive protein

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Low-potassium lettuce 20 g to 40 g/1 dish 6 dishes/2 weeks
Interventions/Control_2
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	Not applicable
Gender	Female
Key inclusion criteria	Adult human undergoing chronic dialysis therapy
Key exclusion criteria	Pregnant History of hyperkalemia
Target sample size	100

Research contact person
Name of lead principal investigator	Junichi Yatabe
Organization	Fukushima Medical University
Division name	Department of Chronic Kidney Disease Initiatives
Address	1 Hikarigaoka, Fukushima, Japan, 960-1295
TEL	024-547-1206
Email	jyatabe@fmu.ac.jp

Public contact
Name of contact person	Junichi Yatabe
Organization	Fukushima Medical University
Division name	Department of Chronic Kidney Disease Initiatives
Address	1 Hikarigaoka, Fukushima, Japan, 960-1295
TEL	024-547-1206
Homepage URL
Email	jyatabe@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
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	社団医療法人養生会　かしま病院 Kashima Hospital 医療法人　かもめクリニック Kamome Clinic 医療法人　ニュータウン腎・内科クリニック Newtown Nephro Medical Clinic 援腎会　すずきクリニック En-Jin-Kai Suzuki Clinic 福島県厚生農業協同組合連合会　坂下厚生総合病院 Bange Kousei General Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 20 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
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	2014 Year 02 Month 03 Day
Last modified on	2016 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015235