UMIN-CTR Clinical Trial

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
Email	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
Email	mtoraishi0824@yahoo.co.jp

Sponsor
Institute	Teikyo University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052623