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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPurdue University

About this trial

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

Eligibility criteria

Qualifiers

Undergoing natural perimenopause

English-speaking

In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition

Disqualifiers

Taking psychoactive drugs

A history of hematological disorders

Trial design

Treatments tested in this trial

  • FeoSol Original Iron Supplement Tablets
  • 21st Century Gelatin Capsules

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators