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

NCT06798584 | Not Yet Recruiting

• 1 other identifier: IRB-2024-506
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Iron; Perimenopause; Iron Deficiency Anemia; Iron Deficiency; Cognitive Function; Quality of Life; Mood; Quality of Family Relationships; Menopause; Perimenopausal Menorrhagia; Abnormal Uterine Bleeding; Menopause Transition; Women's Health

Outcome Measures

Primary Outcomes (19)

• Iron Status Assessment

  The investigators will measure plasma iron (mcg/dL).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will measure total iron binding capacity (TIBC) (mcg/dL).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will measure transferrin saturation (TSAT) (%).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will measure serum ferritin (Ft) (μg/L).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will measure serum transferrin receptor (TfR) (mg/L).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will measure serum hepcidin (ng/mL).

  From enrollment to the end of treatment at 4 months

• Iron Status Assessment

  The investigators will calculate body Fe (mg/kg) using Cook's formula.

  From enrollment to the end of treatment at 4 months

• Inflammation Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Inflammation Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Cognitive Function Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Cognitive Function Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Cognitive Function Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Cognitive Function Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Cognitive Function Assessment

  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.

  From enrollment to the end of treatment at 4 months

• Quality of Life

  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.

  From enrollment to the end of treatment at 4 months

• Quality of Life

  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.

  From enrollment to the end of treatment at 4 months

• Assessment of Mood

  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).

  From enrollment to the end of treatment at 4 months

• Assessment of Family Relationships

  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).

  From enrollment to the end of treatment at 4 months

Study Arms (6)

Iron Sufficient - Placebo

PLACEBO COMPARATOR

Women classified as iron sufficient given a 4-month supply of gelatin capsules

Dietary Supplement: 21st Century Gelatin Capsules

Iron Sufficient - Iron Supplements

EXPERIMENTAL

Women classified as iron sufficient given a 4-month supply of iron supplements

Dietary Supplement: FeoSol Original Iron Supplement Tablets

Iron Deficient - Placebo

PLACEBO COMPARATOR

Women classified as iron deficient given a 4-month supply of gelatin capsules

Dietary Supplement: 21st Century Gelatin Capsules

Iron Deficient - Iron Supplements

EXPERIMENTAL

Women classified as iron deficient given a 4-month supply of iron supplements

Dietary Supplement: FeoSol Original Iron Supplement Tablets

Iron Deficient (Anemic) - Placebo

PLACEBO COMPARATOR

Women classified as anemic given a 4-month supply of gelatin capsules

Dietary Supplement: 21st Century Gelatin Capsules

Iron Deficient (Anemic) - Iron Supplements

EXPERIMENTAL

Women classified as anemic given a 4-month supply of iron supplements

Dietary Supplement: FeoSol Original Iron Supplement Tablets

Interventions

FeoSol Original Iron Supplement Tablets DIETARY_SUPPLEMENT

325 mg of ferrous sulfate containing 65 mg of elemental iron

Iron Deficient (Anemic) - Iron Supplements; Iron Deficient - Iron Supplements; Iron Sufficient - Iron Supplements

21st Century Gelatin Capsules DIETARY_SUPPLEMENT

600 mg

Iron Deficient (Anemic) - Placebo; Iron Deficient - Placebo; Iron Sufficient - Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• Taking psychoactive drugs
• A history of hematological disorders

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Stone Hall

West Lafayette, Indiana, 47907, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency; Metrorrhagia

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura E Murray-Kolb, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura E Murray-Kolb, PhD

CONTACT

765-496-3570; lmurrayk@purdue.edu

Mun S Choi, MS

CONTACT

765-496-6055; mchoi@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Department Head

Model Details: Participants will be classified as iron sufficient, iron deficient, or iron deficient anemic according to the following parameters. To be classified as iron deficient anemic (IDA): Hb between 100 and 119 g/L, and at least 2 of the following iron deficiency parameters: mean corpuscular volume (MCV) \< 80 fL, transferrin saturation (TSAT) \<15%, serum ferritin (Ft) \<15 ug/L, serum transferrin receptor \>8.3 mg/L, serum hepcidin \<8 ng/mL; to be classified as iron deficient without anemia (ID): at least 2 of the abnormal values listed above with a Hb\>=120 g/L; to be classified as iron sufficient (IS): Hb \>=120 g/L, MCV \>80 fL, TSAT \>15%, Ft \>20 ug/L, TfR \< 6 mg/L, and hepcidin \>8 ng/mL. Any participant with a Hb \<100 g/L will be excluded from the study as being too anemic and be referred to a physician for immediate treatment of the anemia. Any participant with a Ft\>200 ug/L will be excluded from the study and advised to follow up with a physician.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

US (1)