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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
FeoSol Original Iron Supplement Tablets
Dietary supplement325 mg of ferrous sulfate containing 65 mg of elemental iron
21st Century Gelatin Capsules
Dietary supplement600 mg
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Iron Sufficient - PlaceboPlacebo comparator 1 intervention
Group B: Iron Sufficient - Iron SupplementsExperimental treatment 1 intervention
Group C: Iron Deficient - PlaceboPlacebo comparator 1 intervention
Group D: Iron Deficient - Iron SupplementsExperimental treatment 1 intervention
Group E: Iron Deficient (Anemic) - PlaceboPlacebo comparator 1 intervention
Group F: Iron Deficient (Anemic) - Iron SupplementsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Iron Status Assessment
The investigators will measure plasma iron (mcg/dL).
Time frame
From enrollment to the end of treatment at 4 months2
Iron Status Assessment
The investigators will measure total iron binding capacity (TIBC) (mcg/dL).
Time frame
From enrollment to the end of treatment at 4 months3
Iron Status Assessment
The investigators will measure transferrin saturation (TSAT) (%).
Time frame
From enrollment to the end of treatment at 4 months4
Iron Status Assessment
The investigators will measure serum ferritin (Ft) (μg/L).
Time frame
From enrollment to the end of treatment at 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: