Iron Supplementation for Menorrhagia
(MENO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLaura E Murray-Kolb, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Purdue University

Trial Summary

What is the purpose of 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

Research Team

Laura E Murray-Kolb, PhD

Principal Investigator

Purdue University

Eligibility Criteria

This trial is for perimenopausal women experiencing heavy menstrual bleeding and who may have iron deficiency or anemia. Participants will visit a research center twice, with a brief midpoint checkup, and take daily supplements or placebo for four months.

Inclusion Criteria

I speak English.

I am in good health with no chronic conditions.

I am experiencing natural symptoms of perimenopause.

Exclusion Criteria

I am taking medication for my mental health.

I have a history of blood disorders.

Treatment Details

Interventions

FeoSol Original Iron Supplement Tablets (Iron Supplement)

Trial OverviewThe study aims to see if FeoSol Original Iron Supplement Tablets can improve cognitive function, mood, family relationships, and overall quality of life in comparison to a placebo (gelatin capsules) in iron-deficient perimenopausal women.

Participant Groups

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Iron Sufficient - Iron SupplementsExperimental Treatment1 Intervention

Women classified as iron sufficient given a 4-month supply of iron supplements

Group II: Iron Deficient - Iron SupplementsExperimental Treatment1 Intervention

Women classified as iron deficient given a 4-month supply of iron supplements

Group III: Iron Deficient (Anemic) - Iron SupplementsExperimental Treatment1 Intervention

Women classified as anemic given a 4-month supply of iron supplements

Group IV: Iron Sufficient - PlaceboPlacebo Group1 Intervention

Women classified as iron sufficient given a 4-month supply of gelatin capsules