UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013058
Receipt number R000015235
Scientific Title Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients
Date of disclosure of the study information 2014/02/03
Last modified on 2016/09/03 13:40:12

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Basic information

Public title

Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients

Acronym

Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients

Scientific Title

Clinical trial on safety and efficacy of low-potassium lettuce for CKD/ESRD patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Junichi Yatabe

Organization

Fukushima Medical University

Division name

Department of Chronic Kidney Disease Initiatives

Zip code


Address

1 Hikarigaoka, Fukushima, Japan, 960-1295

TEL

024-547-1206

Email

jyatabe@fmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junichi Yatabe

Organization

Fukushima Medical University

Division name

Department of Chronic Kidney Disease Initiatives

Zip code


Address

1 Hikarigaoka, Fukushima, Japan, 960-1295

TEL

024-547-1206

Homepage URL


Email

jyatabe@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2013 Year 10 Month 10 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name