Iron Supplementation for Perimenopausal Women with Heavy Bleeding
This study is looking at how heavy bleeding during perimenopause (the time leading up to menopause) and your iron levels affect your quality of life and thinking abilities. Researchers want to see if taking an iron supplement, specifically FeoSol Original Iron Supplement Tablets, can improve iron levels, mood, family relationships, and thinking skills in women who have low iron or iron deficiency anemia. You might be able to join if you are a woman in natural perimenopause, speak English, and are generally healthy. The study will compare the effects of the iron supplement to a placebo (a 21st Century Gelatin Capsule, which has no active medicine). The study plans to enroll 240 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study comparing the effects of an iron supplement to a placebo. It aims to enroll 240 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your iron status will be assessed from enrollment to the end of treatment at 4 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
At a glance
Conditions
NCT06798584
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Stone Hall
West Lafayette, Indianastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Laura E Murray-Kolb, PhD · PRINCIPAL_INVESTIGATOR · Purdue University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure plasma iron (mcg/dL).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure total iron binding capacity (TIBC) (mcg/dL).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure transferrin saturation (TSAT) (%).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure serum ferritin (Ft) (μg/L).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure serum transferrin receptor (TfR) (mg/L).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure CBC parameters (including hemoglobin (Hb) (g/dL), hematocrit (Hct) (%), mean corpuscular volume (MCV) (fL), and red blood cell distribution width (RDW) (fL)), which are measured in whole blood.
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure serum hepcidin (ng/mL).
- Iron Status AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will calculate body Fe (mg/kg) using Cook's formula.
- Inflammation AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure α-1-acid glycoprotein (g/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
- Inflammation AssessmentFrom enrollment to the end of treatment at 4 months
The investigators will measure C-reactive protein (mg/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
- Cognitive Function AssessmentFrom enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Berg Card Sorting Test (# of categories completed and # of perseverative errors) will be performed through the PEBL to assess executive function in participants in a lighting and temperature-controlled testing environment.
- Cognitive Function AssessmentFrom enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Attention Network Task (% correct for accuracy and reaction time, alerting, orienting, and conflict measurements in milliseconds) will be performed through the PEBL to assess alerting, orienting, and conflict in participants in a lighting and temperature-controlled testing environment.
- Cognitive Function AssessmentFrom enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Go Task: The Go/No-Go (% correct for accuracy and reaction time in milliseconds) will be performed through the PEBL to assess the ability to inhibit impulsivity while responding to go cues in participants in a lighting and temperature-controlled testing environment.
- Cognitive Function AssessmentFrom enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Tower of London Task (# of excess moves and planning and solution time in milliseconds) will be performed through the PEBL to assess the efficiency in planning in participants in a lighting and temperature-controlled testing environment.
- Cognitive Function AssessmentFrom enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Sternberg Memory Search Task (% correct for accuracy, reaction time in milliseconds, and # of throughput) will be performed through the PEBL to assess working memory in participants in a lighting and temperature-controlled testing environment.
- Quality of LifeFrom enrollment to the end of treatment at 4 months
Quality of life will be assessed using the self-administered MOS 36-Item Short Form Health Survey (SF-36), with a score ranging from 0 to 100, where higher scores indicate better health.
- Quality of LifeFrom enrollment to the end of treatment at 4 months
Quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL), with a score ranging from 0 to 6, where higher scores indicate worse quality of life.
- Assessment of MoodFrom enrollment to the end of treatment at 4 months
Mood will be assessed using the Beck Depression Inventory-II (BDI-II) (with a score ranging from 0 to 63, where higher scores indicate worse depressive symptoms).
- Assessment of Family RelationshipsFrom enrollment to the end of treatment at 4 months
Family relationships will be assessed using the Family Adaptability and Cohesion Evaluation Scale IV Short Form (FACES-IV-SF) (with a score ranging from 0-1, where scores less than one represents families with problematic functioning).