UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034352 |
|---|---|
| Receipt number | R000039157 |
| Scientific Title | Effect of daily eating habits on serum phosphorus levels and related metabolic indicators |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/10/01 21:48:41 |
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Basic information
Public title
Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Acronym
Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Scientific Title
Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Scientific Title:Acronym
Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between habitual diet and blood phosphorus metabolism indicator and elucidate the dietary factors that cause hyperphosphatemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum phosphorus levels
Habitual phosphorus intakes
Key secondary outcomes
24hour renal phosphorus excretion
Serum PTH, FGF23, vitamin D levels
food sources
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who received a sufficient explanation of the purpose and contents of the study, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document.
Key exclusion criteria
1) Currently, those who have some chronic illness and are undergoing drug treatment.
2) Those who are pregnant, plan for pregnancy during the study period, those who have hope
3) Breastfeeding
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Arai |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL
054-264-5511
arai@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Arai, Masae Sakuma |
Organization
The University of Shizuoka
Division name
Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5511
Homepage URL
arai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
浅井内科医院 Asai Clinic
中條医院 Nakajyo Clinc
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | 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
| 2015 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
cross-sectional study
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2018 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039157
