UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001831 |
|---|---|
| Receipt number | 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 18:46:09 |
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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
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
kozaki-tky@umin.ac.jp
Sponsor or person
Institute
Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001882
