UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049710 |
|---|---|
| Receipt number | R000056587 |
| Scientific Title | Effect of vitamin B12 supplementation on bone metabolic markers in adults with decreased kidney function |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2024/06/10 12:50:07 |
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Basic information
Public title
Effect of vitamin B12 supplementation on bone metabolic markers in adults with decreased kidney function
Acronym
Effect of vitamin B12 supplementation on bone metabolic markers in adults with decreased kidney function
Scientific Title
Effect of vitamin B12 supplementation on bone metabolic markers in adults with decreased kidney function
Scientific Title:Acronym
Effect of vitamin B12 supplementation on bone metabolic markers in adults with decreased kidney function
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of vitamin B12 supplementation on markers related to bone metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from Baseline in Bone Metabolic Markers at Week 4
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
vitamin B12 supplement
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age>=40 years
2) Estimated glomerular filtration rate<60 mL/min/1.73m2
3) Not expected to make significant changes in diet during the study period
4) Subjects who can give written consent to participate in this study
Key exclusion criteria
1) Subjects undergoing chronic dialysis
2) Subjects undergoing osteoporosis treatment
3) Subjects with a history of bone fracture within 6 months
4) Subjects taking steroids
5) Subjects receiving treatment for malignancies
6) Subjects with advanced liver disease
7) Subjects with high alcohol intake
8) Subjects with smoking
9) Subjects with a history of gastrointestinal surgery
10) Subjects with restricted physical activities
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hara |
Organization
Kanazawa University
Division name
Hygiene and Public Health
Zip code
920-8640
Address
13-1 Takara-machi
TEL
0762652218
hara-akinori@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hara |
Organization
Kanazawa University
Division name
Hygiene and Public Health
Zip code
920-0944
Address
13-1 Takara-machi
TEL
0762652218
Homepage URL
hara-akinori@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Medical ethics committee, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
0762652110
rinri@adm.kanazawa-u.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
| 2022 | Year | 12 | Month | 08 | 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
37
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
| 2022 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056587
