UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011380 |
|---|---|
| Receipt number | R000013326 |
| Scientific Title | Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial |
| Date of disclosure of the study information | 2013/08/11 |
| Last modified on | 2015/08/23 01:06:56 |
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Basic information
Public title
Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial
Acronym
Dietary fiber for constipation in hemodialysis patients
Scientific Title
Studies on the effects of polydextrose intake on constipation in Japanese dialysis patients: a triple-blind randomized controlled trial
Scientific Title:Acronym
Dietary fiber for constipation in hemodialysis patients
Region
| Japan |
Condition
Condition
Constipation in chronic hemodialysis patients
Classification by specialty
| Gastroenterology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether administration of a mini-jelly containing a dietary fiber (polydextrose; 10 g/day) improve the function of bowel movements in chronic hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of bowel movements
Key secondary outcomes
#Blood biochemistry (BUN,Cr,Ca,P,Alb, hepatic function)
#Dose and usage frequency of medicines for constipation
#Stool form and abdominal symptom
#Side effects of a dietary fiber
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Mini-jelly containing polydextrose (10g/day)
Interventions/Control_2
Placebo (mini-jelly without polydextrose)
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic hemodialysis patients with constipation
Key exclusion criteria
1) Patients with organic bowel diseases (e.g.; inflammatory bowel disease or colon cancer)
2) Patients who start or change the usage of P, K, cholesterol-binding agents during the study
3) Patients already treated with dietary fibers or Lactobacillus preparations as a supplement
4) Patients hospitalized during the study
5) When an appearance of side effects which seem to be related with dietary fiber mini-jelly or the placebo jelly during the study
6) Patients uncontrolled by hemodialysis during the study
7) Patients showing remarkably poor bowel movements during the study
8) Patients determined by doctors that the study continuation is inappropriate
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikiko Shimada |
Organization
Hidaka Rehabilitation Hospital
Division name
Department of Nutrition
Zip code
Address
2204 Maniwa,Yoshii, Takasaki, Gumma,370-2104, Japan
TEL
027-388-2005
reha-eiyo@hidaka-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikiko Shimada |
Organization
Hidaka rehabilitation hospital
Division name
Department of Nutrition
Zip code
Address
2204 Maniwa,Yoshii, Takasaki, Gumma,370-2104, Japan
TEL
027-388-2005
Homepage URL
reha-eiyo@hidaka-kai.com
Sponsor or person
Institute
Heisei Hidaka clinic
Institute
Department
Personal name
Funding Source
Organization
Medical Corporations Heisei Hidaka clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo University of Agriculture
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
平成日高クリニック
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 11 | 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
The PDX group had significantly increased stool frequency compared to before the PDX intake period: 7.0, 5.0, 8.0, 8.5 bowel movements per week during the PDX study period (week 1-week 4) and 7.3 bowel movements after the end of the study period (p < 0.01).
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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 11 | Month | 30 | Day |
Other
Other related information
The PDX group showed no significant change was observed in the stool score. While the total energy and macronutrient intake levels were unchanged during the study, paired t-test analysis showed that retinol activity equivalents intake was significantly increased in the PDX group.
Clinical biochemistry indexes (e.g., measures of liver and renal function, blood electrolytes, fasting blood glucose, triglyceride, cholesterol, and serum glycoalbumin) did not change significantly after PDX intake for 28 days.
Management information
Registered date
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013326
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
