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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001831
Receipt No. R000001882
Scientific Title Study of fall prevention by vitamin D in the elderly
Date of disclosure of the study information 2009/04/01
Last modified on 2009/03/31

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Basic information
Public title Study of fall prevention by vitamin D in the elderly
Acronym Fall prevention study by vitamin D in the elderly
Scientific Title Study of fall prevention by vitamin D in the elderly
Scientific Title:Acronym Fall prevention study by vitamin D in the elderly
Region
Japan

Condition
Condition Patients attending the outpatient clinic at Kyorin University Hospital or other facilities participating in this project, who are at or over the age of 65 years; who have an experience of falling within one year; and whose creatinine clearance is less than 65ml/min by the Cockcroft-Gault formulas
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Vitamin D is reported to prevent falling not only from improving osteoporosis but also from other factors such as increasing muscle strength and decreasing body sway. Since this is reported outside from Japan, we will test the possibility of preventing falls by vitamin D in the Japanese population.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of falls after 6 months and 1 year
Key secondary outcomes Bone mineral density, bone metabolism markers, neuropsychological function, Fall-related factors such as muscle strength, fall-predicting score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Term: one year Drug: vitamin D (one alpha) Dose: 0.5 ug/day Frequency: every morning
Interventions/Control_2 Term: one year Drug: precipitated calcium carbonate (caltan) Dose: 500 mg/day Frequency: every morning
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients at or over the age of 65 years, who are attending Kyorin University Hospital or other facilities participating in this project, who have a history of falling within one year, and whose creatinine clearance is less than 65mL/min by the Cockcroft-Gault formulas. All subjects or their family must give a written informed consent, especially in case of demented patients.
Key exclusion criteria 1. Bed-ridden patient 2. Patient who has severe liver, GI-tract, or heart disease 3. Parkinson's disease 4. User of a wheel-chair 5. Patient who has paralysis 6. Patient who have a past history of treatment with vitamin D within 6 months 7. Inflammatory degenerative joint disease such as rheumatoid arthritis or osteoarthritis 8. Demented patient who is unable to evaluate a history of falling 9. Patient who has a past history of hypercalcemia or urolithiasis 10. Ineligible patient determined by the attending doctor
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Toba
Organization Kyorin University School of Medicine
Division name Department of Geriatric Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Kozaki
Organization Kyorin University School of Medicine
Division name Department of Geriatric Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL 0422-44-1917
Homepage URL
Email kozaki-tky@umin.ac.jp

Sponsor
Institute Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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
2009 Year 04 Month 01 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
Date of protocol fixation
2006 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 31 Day
Last modified on
2009 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001882

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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