UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009235
Receipt No. R000010846
Scientific Title Study on the safety and effectiveness of rice protein intake in maintenance hemodialysis patients
Date of disclosure of the study information 2012/11/01
Last modified on 2013/10/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on the safety and effectiveness of rice protein intake in maintenance hemodialysis patients
Acronym Niigata KOME (key evaluation of rice proteins' medical benefits) study 2
Scientific Title Study on the safety and effectiveness of rice protein intake in maintenance hemodialysis patients
Scientific Title:Acronym Niigata KOME (key evaluation of rice proteins' medical benefits) study 2
Region
Japan

Condition
Condition Chronic renal failure (maintenance hemodialysis)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prospectively evaluate the safety of rice protein intake in serum phosphate, calcium, sodium, potassium and magnesium concentrations and its effectiveness in nutritional and metabolic parameters in maintenance hemodialysis patients who are stable in general condition but tend to be malnutritional
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in serum phosphate, calcium, sodium, potassium and magnesium concentrations
Key secondary outcomes Changes in the following parameters during the observation period:
1) Clinical symptoms (abdominal symptoms etc)
2) Body weight, BMI, muscle volume and body fat composition
3) Nutritional, metabolic and inflammatory parameters

Adverse events are analyzed with Common Terminology Criteria for Adverse Events v4.0-JCOG when they happen.


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 Intake of rice proteins (5g/day) for 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 Male and Female
Key inclusion criteria Adult male or female maintenance hemodialysis patients who fulfill the following criteria will be included in the study:
1) Tendency of malnutrition (serum albumin concentration = or < 8mg/dl and BMI = or < 22kg/m2)
2) Those who have given written informed consent on the use of their data for the study
Key exclusion criteria 1) Those with severe heart or liver disease
2) Those at perioperative stages, or those with severe infection or serious injury
3) Those with food allergy
4) Those who are considered not eligible for the study by attending doctors due to any medical reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Saito
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Applied Molecular Medicine
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL 025-227-0915
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Saito
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Applied Molecular Medicine
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL 025-227-0915
Homepage URL
Email akisaito@med.niigata-u.ac.jp

Sponsor
Institute Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization The Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 新潟大学医歯学総合病院(新潟県)、向陽メディカルクリニック

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 01 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
2012 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2013 Year 03 Month 20 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 31 Day
Last modified on
2013 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.