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

Part of paid clinical trials in West Lafayette, Indiana.

Sponsor
Purdue University
Study ID
NCT06798584
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • FeoSol Original Iron Supplement Tablets — DIETARY_SUPPLEMENT
    325 mg of ferrous sulfate containing 65 mg of elemental iron
  • 21st Century Gelatin Capsules — DIETARY_SUPPLEMENT
    600 mg

Study Details

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

Key Dates

Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Iron Sufficient - Placebo
    Women classified as iron sufficient given a 4-month supply of gelatin capsules
  • Experimental: Iron Sufficient - Iron Supplements
    Women classified as iron sufficient given a 4-month supply of iron supplements
  • Placebo Comparator: Iron Deficient - Placebo
    Women classified as iron deficient given a 4-month supply of gelatin capsules
  • Experimental: Iron Deficient - Iron Supplements
    Women classified as iron deficient given a 4-month supply of iron supplements
  • Placebo Comparator: Iron Deficient (Anemic) - Placebo
    Women classified as anemic given a 4-month supply of gelatin capsules
  • Experimental: Iron Deficient (Anemic) - Iron Supplements
    Women classified as anemic given a 4-month supply of iron supplements

Primary Outcome Measure

Iron Status Assessment [ Time Frame: From enrollment to the end of treatment at 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stone HallWest LafayetteIndiana47907
Laura E Murray-Kolb, PhD
[email protected]
765-496-3570
Mun S Choi, MS
[email protected]
765-496-6055
Laura E Murray-Kolb, PhD (PRINCIPAL_INVESTIGATOR)

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Stone Hall· West Lafayette, IN

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