UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of effects of acute endurance exercise on serum 25(OH)D levels
Title of the study (Brief title)	Elucidation of effects of acute endurance exercise on serum 25(OH)D levels
Region	Japan

Condition
Condition	Healthy men and women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate whether acute endurance exercise modulates circulating 25 (OH)D levels in healthy young and elderly subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effects of acute endurance exercise on circulating 25(OH)D levels
Key secondary outcomes	Effects of acute endurance exercise on other hormone levels related to vitamin D metabolism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Young Participants were asked to perform a cycling exercise for 30 min at 70% maximal oxygen uptake
Interventions/Control_2	Elderly participants were asked to perform a cycling exercise for 30 min at 70% maximal oxygen uptake
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy young subjects over 18 years old, and healthy elderly subjects over 60 years old
Key exclusion criteria	1.Use of tanning booths or other artificial UV light exposure 2.History or presence of diabetes, heart, liver and kidney diseases, and stoke, eating disorders, gastrointestinal disorders 3.Taking vitamin D supplement or 1,25 vitamin D 4.Physician has placed a restriction on physical exercise
Target sample size	30

Research contact person
Name of lead principal investigator	Mitsuru Higuchi
Organization	Waseda University
Division name	Faculty of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	+81-4-2947-6745
Email	mhiguchi@waseda.jp

Public contact
Name of contact person	Xiaomin Sun
Organization	Waseda University
Division name	Graduate School of Sport Sciences
Address	2-579-15 Mikajima, Tokorozawa, Saitama 359-1192
TEL	+81-4-2947-6745
Homepage URL
Email	gzhtxiaomin@yahoo.co.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Bio-oriented Technology Research Advancement Institution, NARO National Natural Science Foundation of China

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	2017 Year 01 Month 11 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 10 Day
Last modified on	2017 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029458