UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041527 |
|---|---|
| Receipt number | R000047373 |
| Scientific Title | A survey of vitamin D status and development of the predictive model for vitamin D deficiency in Japanese young women |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/08/27 10:29:52 |
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Basic information
Public title
A survey of vitamin D status and development of the predictive model for vitamin D deficiency in Japanese young women
Acronym
A survey of vitamin D status and development of the predictive model for vitamin D deficiency in Japanese young women
Scientific Title
A survey of vitamin D status and development of the predictive model for vitamin D deficiency in Japanese young women
Scientific Title:Acronym
A survey of vitamin D status and development of the predictive model for vitamin D deficiency in Japanese young women
Region
| Japan |
Condition
Condition
Healthy young women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the actual distribution of serum 25-hydroxyvitamin D [25(OH)D] and identify the predictive factors for serum 25(OH)D level in Japanese young women.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum 25-hydroxyvitamin D [25(OH)D] level
Key secondary outcomes
serum intact-PTH level
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) The area of the study
To determine the effect of latitudes on serum 25(OH)D level, this study is performed in four areas (Hokkaido and Tohoku region, from Kanto to Shikoku region, Kyushu and Okinawa region).
(2) 18- 40 ys female at the time of study participation
(3) Having provided voluntary written consent for participation in this study. For subjects under 20 ys of age, parental consent is also required.
Key exclusion criteria
(1) Subjects with comorbidities such as chronic kidney disease, autoimmune disease, inflammatory bowel disease, cancer, liver disease, diabetes mellitus.
(2) Subjects under sun exposure prohibition (e.g. xeroderma pigmentosum)
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwabara |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino, Osaka, 583-8555, Japan
TEL
072-950-2852
akuwabara@rehab.osakafu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwabara |
Organization
Osaka Prefecture University
Division name
Graduate School of Comprehensive Rehabilitation
Zip code
583-8555
Address
3-7-30 Habikino, Habikino, Osaka, 583-8555, Japan
TEL
072-950-2852
Homepage URL
akuwabara@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University
Address
3-7-30 Habikino, Habikino, Osaka, 583-8555, Japan
Tel
072-950-2111
akuwabara@rehab.osakafu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20ek0210131h0001
Org. issuing International ID_1
Japan Agency for Medical Research and Development
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Observational study
We evaluate these indices as below; serum 25(OH)D level, the dietary intake, and the lifestyle during a month before blood correction.
The lifestyle before the coronavirus crisis.
Investigation items are as below: residential area, the season of blood correction, habitual sun exposure time and frequency, sunscreen use, the experience of suntan within the past 12 months, habitual vitamin D intake and fish intake, smoking status, habitual drinking, Physical activity, vitamin D supplement use.
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047373
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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