UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027854 |
|---|---|
| Receipt number | R000027019 |
| Scientific Title | Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2017/06/21 17:41:30 |
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Basic information
Public title
Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes
Acronym
Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures
Scientific Title
Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures in athletes
Scientific Title:Acronym
Effects of combined intake of low-fat milk and vitamin D supplement for the prevention of stress fractures
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of combined intake of low-fat milk and vitamin D supplement on bone metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in bone metabolism markers after 6-month intervention
Key secondary outcomes
Stress fracture incidence rate
Bone mineral density
Bone marrow edema
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Healthy athletes are given a low-fat milk (200ml/day) and vitamin D supplement (1000IU/day) every day for 6 month.
Interventions/Control_2
Healthy athletes are life as usual.
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
| 15 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. More than 15 years of age less than 30 years old
2. Healthy athletes
3. Be able to provide written informed consent
Key exclusion criteria
1. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Fujita |
Organization
Ritsumeikan University
Division name
Graduate School of Sport and Health Science
Zip code
Address
1-1-1 Noji-higashi, Kusatsu, Shiga
TEL
077-561-5229
safujita@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Fujita |
Organization
Ritsumeikan University
Division name
Graduate School of Sport and Health Science
Zip code
Address
1-1-1 Noji-higashi, Kusatsu, Shiga
TEL
077-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
Sponsor or person
Institute
Graduate School of Sport and Health Science, Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Japan Diary Association (J-milk), Dairy Products Health Science Council
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
立命館大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 22 | 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
| 2016 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027019
