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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031447
Receipt No. R000035859
Scientific Title A study for safety evaluation of excess consumption of calcium.
Date of disclosure of the study information 2018/02/25
Last modified on 2018/08/24

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Basic information
Public title A study for safety evaluation of excess consumption of calcium.
Acronym A study for safety evaluation of excess consumption of calcium.
Scientific Title A study for safety evaluation of excess consumption of calcium.
Scientific Title:Acronym A study for safety evaluation of excess consumption of calcium.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines safety of overconsumption (4 weeks) of a test food.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Existence of side effects and adverse events(Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)
Key secondary outcomes Doctor's questions, Blood pressure, pulsation, Weight, body fat percentage, BMI, Blood biochemical test, Hematologic test, Urine analysis (Week 0, Week 2, Week 4, 2 weeks after the end of ingestion of a test food)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of the test foods (255g in a day for 4 weeks)
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Healthy adults aged 20 to 64 years old.
(2)Subjects giving written informed consent.
Key exclusion criteria (1)Subjects who are given continuous treatment by taking medicines.
(2)Individuals who excessively take calcium (total(test foods and usual meals) amount of calcium over 2500mg/day).
(3)Subjects who have previous and/or current medical history of kidney stones, Ureteral stones.
(4)Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results.
(5)Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(6)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(7)Subjects who excessive alcohol intake.
(8)Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(9)Subjects who have previous medical history of drug and/or food allergy.
(10)Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(11)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(12)Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(13)Females who donated over 400mL blood and/or blood components within the last four month to the current study.
(14)Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(15)Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(16)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhi Shimizu
Organization Maruha Nichiro Corporation
Division name Chilled foods department
Zip code
Address 3-2-20, Toyosu, Koto-Ku, Tokyo, 135-8608 Japan
TEL 03-6833-4148
Email har-shimizu@maruha-nichiro.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Mitsumoto
Organization Maruha Nichiro Corporation
Division name Central Research Institute
Zip code
Address 16-2, Wadai, Tsukuba-City, Ibaraki, 300-4295 Japan
TEL 029-864-6712
Homepage URL
Email h-mitsumoto@maruha-nichiro.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Maruha Nichiro Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2018 Year 02 Month 25 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
2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
2018 Year 04 Month 19 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 05 Month 24 Day
Date analysis concluded
2018 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 23 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035859

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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