UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037219 |
|---|---|
| Receipt number | R000042388 |
| Scientific Title | Comparison on absorption rate of food containing calcium in Japanese elderly women |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2020/06/16 12:47:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
info@amy-med.com
Sponsor or person
Institute
Notre Dame Seishin University, Graduate School of Human Life Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042388
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
