UMIN-CTR Clinical Trial

Basic information
Public title	Comparison on absorption rate of food containing calcium in Japanese elderly women
Acronym	CONFIRM Trial
Scientific Title	Comparison on absorption rate of food containing calcium in Japanese elderly women
Scientific Title:Acronym	CONFIRM Trial
Region	Japan

Condition
Condition	Not applicable.
Classification by specialty	Medicine in general Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare calcium absorption rates with calcium carbonate, milk and unical.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratios of total calcium excreted in urine and feces to total calcium intake when calcium carbonate, milk and unical are ingested.
Key secondary outcomes	1) Safety of calcium-containing food, 2) serum calcium level and calcium absorption rate at low calcium diet, 3) correlation between calcium absorption rate and bone metabolism markers, 4) relationship between daily activity and calcium absorption rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Calcium carbonate (Ca:450mg/day) and unical (Ca:450mg/day)for 4 days each.
Interventions/Control_2	Intake of calcium carbonate (Ca:450mg/day) and milk (Ca:450mg/day) for 4 days each.
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	60 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	1) Postmenopausal women aged 60 to 75 years old with written informed consxent 2) Person without chronic constipation or diarrhea
Key exclusion criteria	1) Person with a history of hypersensitivity to milk, calcium carbonate, or unical 2) Person being treated with orthopedic surgery for fractures or bone abnormalities or person who need medication for fractures or bone abnormalities 3) Person with medications that affect calcium absorption for endocrine metabolic diseases 4) Person with difficult stool collection due to digestive disease or resection 5) Person with difficult urin collection due to urinary tract disease 6) Person with difficult to intake regular food due to underlying disease or person treated with diuretics 7) Person participating in other intervention trials 8) Person with acute disease that affects the efficacy or safety of the study 9) Person with hypocalcemia, hypercalcemia, or hypoalbuminemia 10) Person judged to be inappropriate by the investigator
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Miyuki Middle name Last name Imamoto
Organization	Notre Dame Seishin University
Division name	Graduate School of Human Life Sciences
Zip code	700-8516
Address	2-16-9 Ifuku-cho,Kita-ku, Okayama City
TEL	086-252-2773
Email	imamoto@m.ndsu.ac.jp

Public contact
Name of contact person	1st name Tetsuhiko Middle name Last name Yokoyama
Organization	AMY information planning
Division name	Life science
Zip code	134-0083
Address	102, 5-20-6, Nakakasai, Edogawa-ku, Tokyo, Japan
TEL	090-9348-8687
Homepage URL
Email	info@amy-med.com

Sponsor
Institute	Notre Dame Seishin University, Graduate School of Human Life Sciences
Institute
Department

Funding Source
Organization	Calcium Institute, Inc.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nisshinkai, Institutional Review Board
Address	4-4-8 Shinmachi, Nishi-ku, Osaka city, Osaka, 550-0013 Japana
Tel	06-6531-3031
Email	info@nisshinkai.jp

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	2019 Year 07 Month 10 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	2019 Year 02 Month 18 Day
Date of IRB	2019 Year 02 Month 18 Day
Anticipated trial start date	2019 Year 07 Month 15 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 11 Month 11 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 01 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042388