UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054252 |
|---|---|
| Receipt number | R000061944 |
| Scientific Title | Effect of vitamin D on menstrual symptoms in female nursing university students |
| Date of disclosure of the study information | 2024/04/25 |
| Last modified on | 2024/04/24 22:06:05 |
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Basic information
Public title
Effect of vitamin D on menstrual symptoms in female university students
Acronym
Effect of vitamin D on menstrual symptoms in female university students
Scientific Title
Effect of vitamin D on menstrual symptoms in female nursing university students
Scientific Title:Acronym
Effect of vitamin D on menstrual symptoms in female university students
Region
| Japan |
Condition
Condition
Menstrual symptoms
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether vitamin D supplementation alleviates menstrual symptoms in female university students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Distress Questionnaire ; MDQ
Key secondary outcomes
Visual Analogue Scale for pain during menstruation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Take a commercially available vitamin D supplement (12.5microgram/day, 1 tablet/day) for 3 months.
/Control group without supplementation
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Because analysis of serum before and after the intervention was required, the study targeted nursing students at University A who were undergoing antibody testing
Key exclusion criteria
Women with endometriosis, uterine fibroids, ovarian disease, or mental illness
Women using OCP or LEP at the recruitment
Women with complications such as bone disease, hyperkalemia, kidney disease, or congenital metabolic disease that affect vitamin D intake status
Women with liver damage
Women had side effects from taking vitamin D
Women with bleeding tendencies
Women with apple or gelatin allergies
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Yoshioka |
Organization
Doshisha women's of liberal arts/Kyoto prefectural university of medicine
Division name
Graduate School of Nursing Science/School of Nursing
Zip code
6100321/6028566
Address
Kodo, Kyotanabe City, Kyoto / 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo Kyoto City, Kyoto
TEL
0774658631
yokubo@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Yoshioka |
Organization
Kyoto prefectural university of medicine
Division name
School of Nursing
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo Kyoto City, Kyoto
TEL
0752515111
Homepage URL
yokubo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Doshisha women's of liberal arts
Institute
Department
Personal name
Yukako Yoshioka
Funding Source
Organization
Doshisha women's of liberal arts
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha Women's of liberal arts, Academic Information Department, Academic Research Support Division
Address
97-1,minamihokotate, Kodo, Kyotanabe City, Kyoto
Tel
0774658679
research@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
| 2024 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061944
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
