Tokyo, June 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062032) titled 'Effect of Vitamin C Supplementation at Lunch on Premenstrual Syndrome' on June 23.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Premenstrual Syndrome
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Vitamin C supplementation
Interventions/Control_2 - Placebo
Eligibility:
Age-lower limit - 18
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070982
Disclaimer: Curated by HT Syndication.