UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011983 |
|---|---|
| Receipt number | R000014001 |
| Scientific Title | The effect of functional foods on serum phosphorus level in dialysis patients |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2016/07/11 16:25:20 |
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Basic information
Public title
The effect of functional foods on serum phosphorus level in dialysis patients
Acronym
The effect of functional foods on serum phosphorus level
Scientific Title
The effect of functional foods on serum phosphorus level in dialysis patients
Scientific Title:Acronym
The effect of functional foods on serum phosphorus level
Region
| Japan |
Condition
Condition
Renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of functional foods on serum phosphorus level in dialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in serum phosphorus level
Key secondary outcomes
Improvement of bone metabolism and resorption markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Meal with functional foods for three months
Interventions/Control_2
Normal meal for three months
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
Dialysis patients
Key exclusion criteria
Patients with congestive heart failure and severe gastrointestinal diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sahoko Ichihara |
Organization
Mie University
Division name
Graduate School of Regional Innovation Studies
Zip code
Address
1577 Kurimamachiya-cho, Tsu, Mie, Japan
TEL
059-231-5389
saho@gene.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sahoko Ichihara |
Organization
Mie University
Division name
Graduate School of Regional Innovation Studies
Zip code
Address
1577 Kurimamachiya-cho, Tsu, Mie, Japan
TEL
059-231-5389
Homepage URL
saho@gene.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Mie Prefecture Agricultural Research Institute
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
くわな共立クリニック（三重県）
武内病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 07 | 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
| 2013 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2016 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014001
