UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009235 |
|---|---|
| Receipt number | 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 09:34:48 |
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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
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
akisaito@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010846
