UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of daily eating habits on serum phosphorus levels and related metabolic indicators
Title of the study (Brief title)	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	Hidekazu Arai
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	054-264-5511
Email	arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Hidekazu Arai, Masae Sakuma
Organization	The University of Shizuoka
Division name	Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Address	52-1 Yada, Suruga-ku, Shizuoka
TEL	054-264-5511
Homepage URL
Email	arai@u-shizuoka-ken.ac.jp

Sponsor
Institute	The University of Shizuoka
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039157