Unique ID issued by UMIN | UMIN000037219 |
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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 |
Comparison on absorption rate of food containing calcium in Japanese elderly women
CONFIRM Trial
Comparison on absorption rate of food containing calcium in Japanese elderly women
CONFIRM Trial
Japan |
Not applicable.
Medicine in general | Not applicable | Adult |
Others
NO
The purpose of this study is to compare calcium absorption rates with calcium carbonate, milk and unical.
Safety
Exploratory
The ratios of total calcium excreted in urine and feces to total calcium intake when calcium carbonate, milk and unical are ingested.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
2
Prevention
Food |
Intake of Calcium carbonate (Ca:450mg/day) and unical (Ca:450mg/day)for 4 days each.
Intake of calcium carbonate (Ca:450mg/day) and milk (Ca:450mg/day) for 4 days each.
60 | years-old | <= |
75 | years-old | >= |
Female
1) Postmenopausal women aged 60 to 75 years old with written informed consxent
2) Person without chronic constipation or diarrhea
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
32
1st name | Miyuki |
Middle name | |
Last name | Imamoto |
Notre Dame Seishin University
Graduate School of Human Life Sciences
700-8516
2-16-9 Ifuku-cho,Kita-ku, Okayama City
086-252-2773
imamoto@m.ndsu.ac.jp
1st name | Tetsuhiko |
Middle name | |
Last name | Yokoyama |
AMY information planning
Life science
134-0083
102, 5-20-6, Nakakasai, Edogawa-ku, Tokyo, Japan
090-9348-8687
info@amy-med.com
Notre Dame Seishin University, Graduate School of Human Life Sciences
Calcium Institute, Inc.
Other
Nisshinkai, Institutional Review Board
4-4-8 Shinmachi, Nishi-ku, Osaka city, Osaka, 550-0013 Japana
06-6531-3031
info@nisshinkai.jp
NO
2019 | Year | 07 | Month | 10 | Day |
Unpublished
Completed
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 02 | Month | 18 | Day |
2019 | Year | 07 | Month | 15 | Day |
2020 | Year | 09 | Month | 30 | Day |
2019 | Year | 11 | Month | 11 | Day |
2019 | Year | 07 | Month | 01 | Day |
2020 | Year | 06 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042388
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