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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001176
Receipt No. 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

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Basic information
Public title Randomized controlled trial of calcium supplementation
Acronym RCT of calcium
Scientific Title Randomized controlled trial of calcium supplementation
Scientific Title:Acronym RCT of calcium
Region
Japan

Condition
Condition Bone loss (Osteoporosis)
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of calcium supplementation on bone mineral density in postmenopausal women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Tow-year changes in bone mineral density of hip and vertebra
Key secondary outcomes Blood pressure, blood biochemical tests

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Food
Interventions/Control_1 Calcium carbonate tablets (Calcium 250mg/day)
Interventions/Control_2 Calcium carbonate tablets (Calcium 500mg/day)
Interventions/Control_3 Placebo
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria healthy women aged 50-75 years
Key exclusion criteria perimenopausa, users of caulcium supplement, female hormones, or corticosteroids, patients undergoing treatment for osteoporosis, liver diseases, kidney disease, endocrinological deseases, or cancers
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutoshi Nakamura
Organization NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES
Division name Department of Community Preventive Medicine, Division of Social and Environmental Medicine
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata city, 951-8510, JAPAN
TEL 025-227-2125
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazutoshi Nakamura
Organization NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES
Division name Department of Community Preventive Medicine, Division of Social and Environmental Medicine
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata city, 951-8510, JAPAN
TEL 025-227-2125
Homepage URL http://www.med.niigata-u.ac.jp/hyg/carct.html
Email kazun@med.niigata-u.ac.jp

Sponsor
Institute NIIGATA UNIVERSITY GRADUATE SCHOOL OF MEDICAL AND DENTAL SCIENCES, Department of Community Preventive Medicine, Division of Social and Environmental Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 06 Month 06 Day

Related information
URL releasing protocol http://www.med.niigata-u.ac.jp/hyg/carct.html
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22653713
Number of participants that the trial has enrolled
Results
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&#8201;=&#8201;0.027). Per-protocol analysis (&#8805;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&#8201;=&#8201;0.010 and 1.0%, p&#8201;=&#8201;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&#8201;=&#8201;0.077). A low-dose calcium supplement of 500&#8201;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.
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
2008 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 05 Day
Last modified on
2012 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001440

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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