UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007853 |
|---|---|
| Receipt number | R000009247 |
| Scientific Title | Associations between serum vitamin D Level with physical activity and cardiorespiratory fitness in healthy adults |
| Date of disclosure of the study information | 2012/04/27 |
| Last modified on | 2013/11/28 08:48:21 |
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Basic information
Public title
Associations between serum vitamin D Level with physical activity and cardiorespiratory fitness in healthy adults
Acronym
serum vitamin D Level and physical activity and cardiorespiratory fitness
Scientific Title
Associations between serum vitamin D Level with physical activity and cardiorespiratory fitness in healthy adults
Scientific Title:Acronym
serum vitamin D Level and physical activity and cardiorespiratory fitness
Region
| Japan |
Condition
Condition
Vitamin D Deficiency
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study was designed to assess the effects of vitamin D supplementation on physical fitness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiorespiratory fitness,Muscular strength and power,25(OH)D
Key secondary outcomes
Physical activity, Body composition, Inflammatory markers, Bone mineral density,Cardiometabolic risk factors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Vitamin D3
Interventions/Control_2
Placebo
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age between 20-69 years
2.Gives informed consent, agrees to be randomly assigned
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, osteoporosis, pregnancy or lactation
3.Taking vitamin D supplement or 1,25 vitamin D
4.Physician has placed a restriction on physical exercise
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zhen-Bo Cao |
Organization
Waseda University
Division name
Faculty of Sport Science
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
04-2947-4614
zb.cao@aoni.waseda.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zhen-Bo Cao |
Organization
Waseda University
Division name
Faculty of Sport Science
Zip code
Address
2-579-15 Mikajima, Tokorozawa, Saitama,359-1192 Japan
TEL
04-2947-4614
Homepage URL
zb.cao@aoni.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 27 | Day |
Last modified on
| 2013 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009247
