UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052057 |
|---|---|
| Receipt number | R000059417 |
| Scientific Title | The effects of intervention for increasing blood vitamin D in female college students. |
| Date of disclosure of the study information | 2023/09/03 |
| Last modified on | 2024/02/28 13:27:00 |
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Basic information
Public title
The effects of intervention for increasing blood vitamin D in female college students.
Acronym
The effects of intervention for increasing blood vitamin D in female college students.
Scientific Title
The effects of intervention for increasing blood vitamin D in female college students.
Scientific Title:Acronym
The effects of intervention for increasing blood vitamin D in female college students.
Region
| Japan |
Condition
Condition
vitamin D insufficiency and deficiency
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the effects of intervention for increasing blood vitamin D in female college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
25-hydroxyvitamin D before and after intervention 3 months
Key secondary outcomes
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
| Food |
Interventions/Control_1
The intervention group takes 14g of lipid dressing four times a week for three months.
Interventions/Control_2
No dressing is distributed to the control group.
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
| 19 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Vitamin D intake is 8.5 microgram/day or more and 25-hydroxyvitamin D is less than 30.
Key exclusion criteria
A person with diseases affecting the absorption surface of nutrients, liver or kidney problems, and bleeding tendency.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ayana |
| Middle name | |
| Last name | Kasuga |
Organization
Doshisha Women's College of Liberal Arts
Division name
Graduate school of nursing science
Zip code
6100332
Address
97-1 ,Minamihokotate, Kyoutanabeshi, kyoto
TEL
09034431175
ik22002@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Ayana |
| Middle name | |
| Last name | 9k22002 |
Organization
Doshisha Women's College of Liberal Arts
Division name
Graduate school of nursing science
Zip code
6100332
Address
97-1 ,Minamihokotate, Kyoutanabeshi, kyoto
TEL
09034431175
Homepage URL
ik22002@dwc.doshisha.ac.jp
Sponsor or person
Institute
Doshisha Women's College of Liberal Arts
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha Women's College of Liberal Arts
Address
97-1 ,Minamihokotate, Kyoutanabeshi, kyoto
Tel
09034431175
ik22002@dwc.doshisha.ac.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
| 2023 | Year | 09 | Month | 03 | 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
30
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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059417
