UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008361 |
|---|---|
| Receipt number | R000009833 |
| Scientific Title | Multicenter, randomized, double-blind, placebo controlled, parallel group trial to evaluate the effect of Vitamin D supplementation for fall prevention |
| Date of disclosure of the study information | 2012/07/06 |
| Last modified on | 2017/08/17 11:38:55 |
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Basic information
Public title
Multicenter, randomized, double-blind, placebo controlled, parallel group trial to evaluate the effect of Vitamin D supplementation for fall prevention
Acronym
Effect of Vitamin D supplementation for fall prevention
Scientific Title
Multicenter, randomized, double-blind, placebo controlled, parallel group trial to evaluate the effect of Vitamin D supplementation for fall prevention
Scientific Title:Acronym
Effect of Vitamin D supplementation for fall prevention
Region
| Japan |
Condition
Condition
Fall
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fall prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of fall prevention
Key secondary outcomes
Physical function
Fracture incidence
Cognitive function
Mental examination (modified falls efficacy scale)
Blood test
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
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Beverage contained Vitamin D supplement (liquid)
1 drop/day (1,000IU)
1 year(52 weeks)
Interventions/Control_2
Placebo beverage without Vitamin D supplement
1 year(52 weeks)
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
Residents in the social welfare corporation kensyokai associated facilities
Key exclusion criteria
History of kidney stones or ureterolithiasis.
Clinically significant hepatic, cardiac, or renal insufficiency
Hypercalcemia
Malabsorption syndrome
Consumption of medications known to interfere with vitamin D metabolism
History of hypersensitivity reactions to vitamin D
Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge
Subject who refuse to participate in
this study
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Enishi |
Organization
Tokushima university
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7240
enishi.tetsuya@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Enishi |
Organization
Tokushima university
Division name
Division of Rehabilitation, Tokushima University Hospital
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7240
Homepage URL
enishi.tetsuya@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Corporation Kensyokai
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2012 | Year | 07 | Month | 06 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 05 | Day |
Last modified on
| 2017 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009833
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
