What this study is
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
What's being tested
- FeoSol Original Iron Supplement Tablets
Intervention · DIETARY SUPPLEMENT
325 mg of ferrous sulfate containing 65 mg of elemental iron
- 21st Century Gelatin Capsules
Intervention · DIETARY SUPPLEMENT
600 mg
Study details
- Official title
- Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
- Sponsor
- Purdue University
- Conditions
- Iron Deficiency Anemia Treatment · Iron Deficiency · Iron Deficiency (Without Anemia)
- Enrolling
- 240 people
- Starts
- 2025-03-01
- Est. completion
- 2025-12
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- Taking psychoactive drugs
- A history of hematological disorders
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStone Hall
West Lafayette, Indiana, United States
- Laura E Murray-Kolb, PhD · Contact765-496-3570lmurrayk@purdue.edu
- Mun S Choi, MS · Contact765-496-6055mchoi@purdue.edu
- Laura E Murray-Kolb, PhD · Principal investigator
Study team
Sponsor
Purdue University
Study ID IRB-2024-506
Principal investigator
Laura E Murray-Kolb, PhD
Purdue University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.