UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062032 |
|---|---|
| Receipt number | R000070982 |
| Scientific Title | Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 17:50:17 |
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Basic information
Public title
Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome
Acronym
Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome
Scientific Title
Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome
Scientific Title:Acronym
Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome
Region
| Japan |
Condition
Condition
Premenstrual Syndrome
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of vitamin C supplementation at lunch on premenstrual syndrome (PMS) symptoms in women with PMS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PMS scores before and after the intervention
Key secondary outcomes
DRSP scores, Objective assessment of sleep and physical activity, Basal body temperature, Dietary intake, High-sensitivity C-reactive protein (hs-CRP), Iron deficiency assessment, Urinary metabolites, Presenteeism, Anxiety and depressive symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Vitamin C supplementation
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Females aged 18 to 39 years.
Regular menstrual cycles (25 to 38 days).
Presence of premenstrual syndrome.
Habitual breakfast consumption.
No current use of vitamin C containing supplements.
Availability to participate throughout the study period and attend scheduled laboratory visits.
Ability to download and use the designated smartphone application.
Key exclusion criteria
Highly irregular daily schedules (including night-shift or rotating shift work).
History of gynecological disorders (e.g., ovarian cysts, uterine fibroids, or reproductive malignancies).
History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorders, or depression).
Current use of sex hormone therapies or anti-hormonal treatments.
Dietary restrictions or medical nutrition therapy.
Regular use of sleep medications or sleep-promoting supplements.
Allergy to any ingredients of the study supplement.
Planned travel across time zones exceeding 2 hours during the study period.
Deemed unsuitable for participation by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
07026426103
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Department of Public Health and Health Policy
Zip code
734-0037
Address
Kasumi 1-2-3, Hiroshima-shi, Hiroshima
TEL
07026426103
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University
Address
1-1-1 Kagamiyama, Higashihiroshima, Hiroshima, Japan
Tel
082-257-1551
ed-ken-zai@office.hiroshima-u.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
| 2026 | Year | 06 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070982
