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Effect of Vitamin E Supplement on Chronic Insomnia Disorder in Postmenopausal Women: A Prospective, Double-blinded Randomized Controlled Trial

Effect of mixed-tocopherol supplement on chronic insomnia disorder in postmenopausal women

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220405002
Enrollment
144
Registered
2022-04-05
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic insomnia chronic insomnia insomnia lack of sleep menopause postmenopausal woman

Interventions

Participants in the vitamin E group received oral mixed-tocopherol 400 units once daily for 1 month. The placebo group received identical placebo capsules in the same regimen. Participants were encour
mixed tocopherol ,placebo

Sponsors

Faculty of Medicine, Ramathibodi Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women, defined as women who have had amenorrhea for a consecutive 12 months or who have undergone previous bilateral oophorectomy, Informed consent was provided by all participants. Inclusion criteria were postmenopausal women who presented with chronic insomnia and met diagnostic criteria based on the American Academy of Sleep Medicine's International Classification of Sleep Disorders, Third Edition (4) and PSQI score > 5.

Exclusion criteria

Exclusion criteria: Hot flushes, contraindications to vitamin E intake (for example, currently taking an antiplatelet or anticoagulant, severe hepatic or renal disease, etc.), psychiatric disease with prescribing medication, caffeine consumption of more than 2 shots per day, night shift workers, and uncontrolled diabetes were all exclusion criteria.

Design outcomes

Primary

MeasureTime frame
chronic insomnia improvement 1 month the Pittsburgh Sleep Quality Index (PSQI) score

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactOrawin Vallibhakara

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

orawinra38@gmail.com6622011416

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026