UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043931 |
|---|---|
| Receipt number | R000050123 |
| Scientific Title | A study of deficiency of vitamin K and D for osteoporosis of Severe Motor and Intellectual Disability |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2023/04/17 13:19:51 |
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Basic information
Public title
A study of deficiency of vitamin K and D for osteoporosis of Severe Motor and Intellectual Disability
Acronym
A study of deficiency of vitamin K and D for osteoporosis of Severe Motor and Intellectual Disability
Scientific Title
A study of deficiency of vitamin K and D for osteoporosis of Severe Motor and Intellectual Disability
Scientific Title:Acronym
A study of deficiency of vitamin K and D for osteoporosis of Severe Motor and Intellectual Disability
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Pediatrics | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the deficiency of vitamin D and vitamin K by measuring the serum 25(OH)D, ucOC and direct vitamin K level and to establish the protocol of vitamin D and K supplement in SMID patients
Basic objectives2
Others
Basic objectives -Others
to assess the role of vitamin D in Gla-OC
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the serum 25(OH)D,ucOC and direct vitamin K level in SMID patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We plan to measure serum vitamin D, ucOC and vitamin K using residual blood sample at annual medical check.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient of more than 20 years that an agreement was obtained from the person, the family or the gardians with full understanding for detailed explanation
Key exclusion criteria
A person corresponding to either condition as follows
1) A person whose residual blood sample is not sufficient to the examination
2) A person whom the principal investigator or co-investigators judges to be inappropriate as a study subject
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Medical and Dental University
Division name
Rehabilitation Medicine
Zip code
168-0062
Address
1-5-45, Yushima, Bumkyo-ku, Tokyo,Japan
TEL
03-5804-5648
t_sakai.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Medical and Dental University
Division name
Rehabilitation Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
09011121295
Homepage URL
t_sakai.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
GRANT-IN-AID FOR SCIENTIFIC RESEARCH
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035648
t_sakai.orth@tmd.ac.jp
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
| 2021 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050123
| 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 |
