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NOT YET RECRUITING
NCT06798584
NA

How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?

Sponsor: Purdue University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: * What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? * How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition. Each participant will: * Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue * Make a very brief visit at midpoint (about 10 minutes) for a checkup * Take a daily study supplement or placebo for 4 months

Official title: Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-03-01

Completion Date

2025-12

Last Updated

2025-02-13

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

FeoSol Original Iron Supplement Tablets

325 mg of ferrous sulfate containing 65 mg of elemental iron

DIETARY_SUPPLEMENT

21st Century Gelatin Capsules

600 mg

Locations (1)

Stone Hall

West Lafayette, Indiana, United States