Iron Supplementation for Menorrhagia

(MENO Trial)

Overseen By Mun S Choi, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Purdue University

Must not be taking: Psychoactive drugs

Disqualifiers: Hematological disorders, others

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how iron levels and heavy menstrual bleeding during menopause affect women's thinking, mood, and relationships. It tests whether iron supplements, such as FeoSol Original Iron Supplement Tablets, can improve these areas for women with low iron or anemia. Participants will take either iron supplements or a placebo (a pill with no active ingredient) for four months. This trial suits English-speaking women experiencing natural menopause who are generally healthy and have no history of blood disorders. As an unphased trial, it provides a unique opportunity to contribute to understanding how iron supplementation can enhance quality of life during menopause.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking psychoactive drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that FeoSol Original Iron Supplement Tablets are generally safe and have been in use for over 70 years. They often treat iron deficiency anemia, which occurs when the body lacks enough iron to produce healthy red blood cells. While these supplements are effective, they can cause side effects, most commonly affecting the stomach, such as nausea or constipation.

Taking too much iron can be dangerous, especially for young children. However, when used as directed, most people tolerate them well. Always follow the dosage instructions and consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of FeoSol Original Iron Supplement Tablets for menorrhagia because they offer a straightforward approach to addressing iron deficiency, which is a common issue for women with heavy menstrual bleeding. Unlike traditional treatments that might focus on hormonal regulation or surgical interventions, these supplements aim to directly replenish iron levels in the body. This can help improve energy levels and overall health more naturally and with fewer side effects. Additionally, by targeting specific groups—like those who are iron sufficient, iron deficient, or anemic—the supplements could provide tailored benefits that standard treatments don't typically address.

What evidence suggests that this trial's treatments could be effective for improving cognitive function and quality of life in perimenopausal women?

This trial will evaluate the effectiveness of iron supplementation for women with menorrhagia. Studies have shown that iron supplements effectively improve iron levels in women with heavy periods. Research indicates that most women absorb the iron from these supplements well, increasing their overall iron levels. One study found that taking iron tablets did not worsen menstrual bleeding, indicating they are generally safe in this regard. Iron deficiency is common in women aged 12 to 49 due to menstrual cycles, and iron supplements may help improve overall health. Feosol Original is a strong iron supplement containing 65 mg of ferrous sulfate, providing a significant boost to daily iron intake. Participants in this trial will be divided into groups based on their iron status, receiving either iron supplements or a placebo. ^{4 6 7 8 9}

Who Is on the Research Team?

Laura E Murray-Kolb, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for perimenopausal women experiencing heavy menstrual bleeding and who may have iron deficiency or anemia. Participants will visit a research center twice, with a brief midpoint checkup, and take daily supplements or placebo for four months.

Inclusion Criteria

I am in good health with no chronic conditions.

I am experiencing natural symptoms of perimenopause.

Exclusion Criteria

I am taking medication for my mental health.

I have a history of blood disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Randomization and Baseline Assessment

Participants are randomized to treatment groups and baseline assessments are conducted

1 week

1 visit (in-person)

Treatment

Participants receive daily iron supplements or placebo for 4 months

16 weeks

2 visits (in-person), weekly phone calls or texts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FeoSol Original Iron Supplement Tablets

Trial Overview The study aims to see if FeoSol Original Iron Supplement Tablets can improve cognitive function, mood, family relationships, and overall quality of life in comparison to a placebo (gelatin capsules) in iron-deficient perimenopausal women.

How Is the Trial Designed?

Group I: Iron Sufficient - Iron Supplements Experimental Treatment 1 Intervention

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

Group II: Iron Deficient - Iron Supplements Experimental Treatment 1 Intervention

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

Group III: Iron Deficient (Anemic) - Iron Supplements Experimental Treatment 1 Intervention

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

Group IV: Iron Sufficient - Placebo Placebo Group 1 Intervention

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

Group V: Iron Deficient - Placebo Placebo Group 1 Intervention

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

Group VI: Iron Deficient (Anemic) - Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Published Research Related to This Trial

Ferric carboxymaltose (FCM) is an effective treatment for iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding, showing significant improvements in ferritin and hemoglobin levels within 6 weeks after treatment in a study of 120 women aged 40 and older.

The safety profile of FCM was confirmed, with significant increases in red blood cell indices also observed, indicating that the benefits of treatment were sustained even 12 weeks post-infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric carboxymaltose for treatment of iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding. Hagras, AM., Hussein, NA., Abdelazim, I., et al.[2023]

Oral iron supplementation with ferrous sulfate (FeSO₄) leads to significantly higher levels of non-transferrin-bound iron (NTBI) in the bloodstream compared to other iron compounds, which raises safety concerns for young children with malaria.

In contrast, iron compounds like sodium iron ethylenediaminetetraacetic acid (NaFeEDTA) and iron polymaltose show negligible NTBI responses, suggesting they may be safer alternatives for iron supplementation in areas where malaria is prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral administration of ferrous sulfate, but not of iron polymaltose or sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), results in a substantial increase of non-transferrin-bound iron in healthy iron-adequate men. Schümann, K., Solomons, NW., Romero-Abal, ME., et al.[2022]

The 'Safe Iron Study' is the first clinical trial to evaluate the safety and efficacy of novel iron supplements, comparing them to traditional ferrous sulfate in healthy adults, aiming to address the adverse effects associated with current iron treatments.

The study will assess whether these new iron forms can improve iron status without increasing risks of malaria, bacterial infections, or gut inflammation, potentially leading to safer options for treating iron deficiency and anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study. Lewis, ED., Wu, D., Mason, JB., et al.[2023]

Citations

1. withpower.com withpower.com/trial/iron-supplementation-for-menorrhagia-cbd49

Iron Supplementation for Menorrhagia (MENO Trial) Research shows that iron supplements can effectively improve iron levels in women with heavy menstrual bleeding, as most women absorbed more iron from the ...

2. ctv.veeva.com ctv.veeva.com/study/how-does-perimenopausal-menorrhagia-affect-womens-quality-of-life-and-cognitive-function

How Does Perimenopausal Menorrhagia Affect Women's ... The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10965019/

The effect of iron supplementation on menstrual bleeding ... The results showed that taking iron tablets during menstrual bleeding did not lead to increased menstrual bleeding. In the study by Bani et al., ...

4. feosol.com feosol.com/blogs/iron-info/iron-and-menstruation?srsltid=AfmBOoo9MUss64OENDWbRJeThjHOipmOpo1aWuO8a9oAaZurDiVSNodD

Iron and Menstruation Women in this large age group (spanning age 12 to 49) have an increased risk of developing iron deficiency anemia for two main reasons.

5. feosol.com feosol.com/products/feosol-original?srsltid=AfmBOoqf7zWr8o94jD4jaY2pdrTh_HolAItsmHCwY6jNpqB0KerwipYn

Feosol® Original High potency Feosol Original uses ferrous sulphate, a time-tested form of iron. Each Feosol Original contains 65 mg which provides 361% of Daily Value.

6. feosol.com feosol.com/products/feosol-original?srsltid=AfmBOorG4dGuym8LUG8o3aD-mtjUtFXDp4xJN5gMUQF9sIQX5NPxKbIl

Feosol® Original Feosol® Original is a classic iron supplement, safe and time tested for more than 7 decades.

7. drugs.com drugs.com/cdi/feosol-iron-tablets-and-capsules.html

FeoSol (Iron Tablets and Capsules) Information Warning. Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age.

8. reference.medscape.com reference.medscape.com/drug/feosol-carbonyl-fe-icar-c-carbonyl-iron-342171

Feosol, Icar C (carbonyl iron) dosing, indications, ... Medscape - Iron deficiency anemia dosing for Feosol, Icar C (carbonyl iron), frequency-based adverse effects, comprehensive interactions, contraindications, ...

9. feosol.com feosol.com/products/feosol-complete?srsltid=AfmBOorr8oDgehfwVdfrtMM0yVUkROzF5-uQWVPsLvNEEXETiWQwyRxG

Feosol® Complete Feosol® Original provides a powerful boost to your energy and immune system with small, once-daily coated tablets that support red blood cell production*.