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

NCT06798584 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-02-13

No results posted yet for this study

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

Conditions

  • Iron Deficiency Anemia Treatment
  • Iron Deficiency
  • Iron Deficiency (Without Anemia)

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

Sponsors & Collaborators

  • Purdue University

    lead OTHER

Principal Investigators

  • Laura E Murray-Kolb, PhD · Purdue University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798584 on ClinicalTrials.gov