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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014380
Receipt No. 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

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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
Email 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
Email sakuma@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016740

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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