UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000606 |
|---|---|
| Receipt number | 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 17:56:47 |
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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
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
ishijin@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000731
