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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000606
Receipt No. R000000731
Scientific Title Treatment effect of dietary fiber on serum phosphorus and quality of life in hemodialysis patients with constipation
Date of disclosure of the study information 2007/02/10
Last modified on 2008/02/11

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Basic information
Public title Treatment effect of dietary fiber on serum phosphorus and quality of life in hemodialysis patients with constipation
Acronym Effect of dietary fiber in hemodialysis patients with constipation
Scientific Title Treatment effect of dietary fiber on serum phosphorus and quality of life in hemodialysis patients with constipation
Scientific Title:Acronym Effect of dietary fiber in hemodialysis patients with constipation
Region
Japan

Condition
Condition Constipation in hemodialysis patients
Classification by specialty
Gastroenterology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know the effects of the dietary fibers on reduction of serum phosphorus and quality of life in hemodialysis patients with constipation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Serum phosphorus
Key secondary outcomes Evaluation of patient's QOL
Does and frequency of laxatives
Frequency of defecation
Side effects of fibers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 dietary fiber
Interventions/Control_2 placebo (dextrin)
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 hemodialysis patients with constipation
Key exclusion criteria patients with organic bowel disease (e.g. inflammatory bowel disease or colon cancer)
patients treated with morphine and/or opioid
patients already treated with dietary fibers as supplement
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Ishikawa
Organization Mie University Hospital
Division name Nephrology
Zip code
Address 2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL 059-231-5403
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Ishikawa
Organization Mie University Hospital
Division name Nephrology
Zip code
Address 2-174 Edobashi, Tsu, Mie, 514-8507, Japan
TEL 059-231-5403
Homepage URL
Email ishijin@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University School of Medicine
Institute
Department

Funding Source
Organization Japan Dialysis Outcome Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) TAIYO KAGAKU Corporation

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

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 10 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
2006 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 12 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 03 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 10 Day
Last modified on
2008 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000731

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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