UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046325 |
|---|---|
| Receipt number | R000052623 |
| Scientific Title | Study of target amount of vitamin D intake for athletes |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2021/12/08 17:14:25 |
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Basic information
Public title
Study of target amount of vitamin D intake for athletes
Acronym
Study of target amount of vitamin D intake for athletes
Scientific Title
Study of target amount of vitamin D intake for athletes
Scientific Title:Acronym
Study of target amount of vitamin D intake for athletes
Region
| Japan |
Condition
Condition
Insufficiency and deficiency of vitamin D
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify change in 25OHD concentration by vitamin D3 supplementation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change(rate of change) of serum 25OHD concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
vitamin D3 supplementation
1 tablete per day (vitamin D3 25 micrrgram)
31 days
Interventions/Control_2
placebo tablet supplementation
1 tablet per day
31 days
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Male players belonging to the Teikyo University Ekiden Race Team
Key exclusion criteria
Injury
Non-participation of practice
Use of calcium and vitamin D supplements
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MAMI |
| Middle name | |
| Last name | TORAISHI |
Organization
Teikyo university
Division name
Institute of Sports Science & Medicine
Zip code
192-0395
Address
359 otsuka Hachiouji City Tokyo
TEL
042-690-5588
mtoraishi0824@yahoo.co.jp
Public contact
Name of contact person
| 1st name | MAMI |
| Middle name | |
| Last name | TORAISHI |
Organization
Teikyo University
Division name
Institute of Sports Science & Medicine
Zip code
192-0395
Address
359 otsuka Hachiouji City Tokyo
TEL
042-690-5588
Homepage URL
mtoraishi0824@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
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
Teikyo University
Address
2-11-1 Kaga Itabashi Tokyo
Tel
03-3964-1211
mtoraishi0824@yahoo.co.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 | 12 | 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
34
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
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052623
