Unique ID issued by UMIN | UMIN000001176 |
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Receipt number | R000001440 |
Scientific Title | Randomized controlled trial of calcium supplementation |
Date of disclosure of the study information | 2008/06/06 |
Last modified on | 2012/12/05 17:28:37 |
Randomized controlled trial of calcium supplementation
RCT of calcium
Randomized controlled trial of calcium supplementation
RCT of calcium
Japan |
Bone loss (Osteoporosis)
Not applicable |
Others
NO
To clarify the effect of calcium supplementation on bone mineral density in postmenopausal women
Efficacy
Confirmatory
Pragmatic
Not applicable
Tow-year changes in bone mineral density of hip and vertebra
Blood pressure, blood biochemical tests
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
3
Prevention
Medicine | Food |
Calcium carbonate tablets (Calcium 250mg/day)
Calcium carbonate tablets (Calcium 500mg/day)
Placebo
50 | years-old | <= |
75 | years-old | >= |
Female
healthy women aged 50-75 years
perimenopausa, users of caulcium supplement, female hormones, or corticosteroids, patients undergoing treatment for osteoporosis, liver diseases, kidney disease, endocrinological deseases, or cancers
450
1st name | |
Middle name | |
Last name | Kazutoshi Nakamura |
NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES
Department of Community Preventive Medicine, Division of Social and Environmental Medicine
1-757 Asahimachi-dori, Chuo-ku, Niigata city, 951-8510, JAPAN
025-227-2125
1st name | |
Middle name | |
Last name | Kazutoshi Nakamura |
NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES
Department of Community Preventive Medicine, Division of Social and Environmental Medicine
1-757 Asahimachi-dori, Chuo-ku, Niigata city, 951-8510, JAPAN
025-227-2125
http://www.med.niigata-u.ac.jp/hyg/carct.html
kazun@med.niigata-u.ac.jp
NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES, Department of Community Preventive Medicine, Division of Social and Environmental Medicine
Grant-in-Aid for Scientific Research (B)
Japan
NO
2008 | Year | 06 | Month | 06 | Day |
http://www.med.niigata-u.ac.jp/hyg/carct.html
Published
http://www.ncbi.nlm.nih.gov/pubmed/22653713
Intention-to-treat analysis showed less dramatic decreases in spinal BMD for the 500-mg/d calcium supplement group compared to the placebo group (1.2% difference over 2 years, p = 0.027). Per-protocol analysis (≥80% compliance) revealed that spinal BMD for the 500-mg/d and 250-mg/d calcium supplement groups decreased less than the placebo group (1.6%, p = 0.010 and 1.0%, p = 0.078, respectively), and that femoral neck BMD for the 500-mg/d calcium supplement group decreased less relative to the placebo group (1.0%, p = 0.077). A low-dose calcium supplement of 500 mg/d can effectively slow lumbar spine bone loss in perimenopausal and postmenopausal women with habitually low calcium intake, but its effect on the femoral neck is less certain. Calcium supplementation dosage should thus be reassessed.
Completed
2008 | Year | 04 | Month | 15 | Day |
2008 | Year | 11 | Month | 01 | Day |
2010 | Year | 11 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2008 | Year | 06 | Month | 05 | Day |
2012 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001440
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