UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014380 |
|---|---|
| Receipt number | R000016740 |
| Scientific Title | A study of effective dietary therapy to control of hyperphosphatemia |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2015/01/26 20:41:33 |
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Basic information
Public title
A study of effective dietary therapy to control of hyperphosphatemia
Acronym
A study of effective dietary therapy to control of hyperphosphatemia
Scientific Title
A study of effective dietary therapy to control of hyperphosphatemia
Scientific Title:Acronym
A study of effective dietary therapy to control of hyperphosphatemia
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of nocturnal eating on phosphorus metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum phosphorus level
Key secondary outcomes
Urinary phosphorus excretion
Serum parathyroid hormone level
Serum FGF23 level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Dinner time is at 17:30.
Interventions/Control_2
Dinner time is at 22:30.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Subjects who are competent to consent
Key exclusion criteria
smoking
history or medication use of glucose tolerance, renal, hepatic dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masae Sakuma |
Organization
University of Shizuoka
Division name
Graduate school of integrated pharmaceutical and nutritional sciences
Zip code
Address
52-1, Yada, Suruga-ku, Shizuoka
TEL
054-264-5596
sakuma@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masae Sakuma |
Organization
University of Shizuoka
Division name
Graduate school of integrated pharmaceutical and nutritional sciences
Zip code
Address
52-1, Yada, Suruga-ku, Shizuoka
TEL
054-264-5596
Homepage URL
sakuma@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 27 | 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 | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016740
