UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001176
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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