Iron Supplementation for Iron-Deficiency Anemia

Overseen By Kathleen A Groesch, MS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Southern Illinois University

Disqualifiers: Severe IDA, Hemoglobinopathy, Gastric ulcers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for taking iron supplements to treat iron-deficiency anemia in pregnant women. Researchers are testing two methods: taking a ferrous sulfate pill daily or every other day, both with the same iron dose. The trial seeks pregnant women who are less than 30 weeks along and have been diagnosed with anemia (low iron levels in the blood). As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and the trial seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

A previous study widely used ferrous sulfate and considered it the standard treatment for iron-deficiency anemia. Research has shown that most people generally tolerate it well. Common side effects include upset stomach, constipation, or diarrhea, which are usually mild and manageable by adjusting the dose or timing of the supplement.

Reports indicate that ferrous sulfate is safe when taken as directed. Rarely, some individuals might experience more serious side effects like severe allergic reactions, but this is uncommon. For those considering participation in a trial involving ferrous sulfate, these findings suggest it is a well-studied and safe option for treating iron deficiency. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ferrous sulfate for treating iron-deficiency anemia because it explores different dosing strategies that could improve patient outcomes. Unlike the traditional daily supplementation approach, this study is testing both daily and alternate-day dosing of ferrous sulfate, each providing an equivalent elemental iron dose of 65 mg. The alternate-day dosing might offer a more tolerable option for patients, potentially reducing side effects like gastrointestinal discomfort commonly associated with daily iron supplements. This flexibility in dosing could lead to better adherence and effectiveness in managing anemia.

What is the effectiveness track record for ferrous sulfate in treating iron-deficiency anemia?

Research has shown that ferrous sulfate effectively treats iron-deficiency anemia. One study found it worked for 86.7% of children with this condition. In this trial, participants will receive either a daily dose or an alternate daily dose of ferrous sulfate, with each pill containing 65 mg of elemental iron. Taking iron every other day may enhance absorption compared to daily intake. Overall, ferrous sulfate is a proven treatment for increasing iron levels and managing anemia. ^{4 6 7 8 9}

Who Is on the Research Team?

Yahia Zeino, MD

Principal Investigator

Southern Illinois University School of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant individuals diagnosed with iron deficiency anemia. Participants should be willing to take oral iron supplements and have no health conditions that would interfere with the study.

Inclusion Criteria

Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (hemoglobin under 10.5 g/dL and ferritin under 15 mcg/L)

Exclusion Criteria

Patients who experience admission for antepartum bleed

I have had gastric bypass surgery in the past.

I have been diagnosed with a placental condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Baseline visit where subjects undergo a blood draw to assess hemoglobin, ferritin, and sTfR levels

1 day

1 visit (in-person)

Treatment

Participants receive either daily or alternate day oral iron supplementation for iron deficiency anemia

8 weeks

Regular follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ferrous Sulfate

Trial Overview The study is testing if taking iron pills every other day (Group 2) is as effective as taking them daily (Group 1) in treating anemia during pregnancy. Each participant will receive a pill containing ferrous sulfate, providing 65 mg of elemental iron.

How Is the Trial Designed?

Group I: 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill Experimental Treatment 1 Intervention

alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Group II: 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill Experimental Treatment 1 Intervention

daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

Who Is Running the Clinical Trial?

Southern Illinois University

Lead Sponsor

Trials

39

Recruited

16,200+

Published Research Related to This Trial

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]

Iron supplementation (100 mg/day) significantly improved hemoglobin levels and antioxidant enzyme activity in 117 anemic women over 100 days, indicating its efficacy in treating iron deficiency anemia.

However, the treatment also increased oxidative stress markers and caused more side effects in women with mild anemia compared to those with moderate or severe anemia, suggesting that iron supplementation should be tailored to individual needs rather than given universally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral iron supplementation leads to oxidative imbalance in anemic women: a prospective study. Tiwari, AK., Mahdi, AA., Chandyan, S., et al.[2013]

In a study analyzing 287 clinical records of young infants, ferrous sulfate was prescribed as a preventive therapy for iron deficiency anemia in 100% of cases, indicating strong adherence to the recommendation for iron supplementation.

However, only 18.1% of the prescriptions met all five criteria for adequacy, with the lowest compliance seen in dosage (29.2%), highlighting the need for improved practices in prescribing iron supplements to ensure effective prevention of anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the prescription pattern of ferrous sulfate as a therapy for preventing iron deficiency anemia in infants. Vásquez-Guzmán, RA., Solano-Ceh, A., Villarreal-Ríos, E., 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]

In a study of 514 pregnant Israeli women, those who took a daily supplement of ferrous sulfate (100 mg elemental iron) experienced significantly less reduction in hemoglobin levels compared to those who did not take the supplement, indicating its efficacy in preventing anemia during pregnancy.

Despite the benefits, 40 out of the 200 women on the iron supplement developed anemia after the fifth month, suggesting that while the supplement is helpful, monitoring is necessary as pregnancy progresses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anemia of pregnancy: evaluation of the effectiveness of routine dietary supplementation program in an Israeli community. Palgi, A., Levi, S., Reshef, A.[2019]

Pediatricians in Rosario view iron deficiency anemia as a significant health issue, primarily linked to poor dietary quality, and they follow national standards in their clinical practice.

To improve management of iron deficiency anemia, pediatricians suggest implementing workshops on anemia and providing more palatable iron supplements to enhance adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The perspective of primary health care pediatricians regarding childhood anemia and iron supplementation. Sguassero, Y., Guerrero, MM., Romero, M.[2022]

In a study of 133 non-anemic children receiving ferrous sulfate supplements for six months, 56.7% showed high adherence to the supplementation, while 43.3% had low adherence, indicating a significant gap in compliance.

Both high and low adherence groups demonstrated limited knowledge about anemia and its prevention, highlighting the need for better education and support from health services to improve adherence and understanding of iron supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Problems of adherence to the program of prevention of iron deficiency anemia and supplementation with iron salts in the city of Viçosa, Minas Gerais, Brazil]. Azeredo, CM., Cotta, RM., da Silva, LS., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188945/

Efficacy of Ferrous Sulphate in the Management of Iron ... [8]. A study reported that ferrous sulfate was (86.7%) effective among children in the management of iron deficiency anemia [9].

2. emedicine.medscape.com emedicine.medscape.com/article/202333-treatment

Iron Deficiency Anemia Treatment & Management Although the traditional dosage of ferrous sulfate is 325 mg (65 mg of elemental iron) orally three times a day, lower doses (eg, 15-20 mg of ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819337

Optimal Oral Iron Therapy for Iron Deficiency Anemia ... Furthermore, compared with daily iron dosing, alternate-day iron dosing showed 34% higher rate of iron absorption. However, the association of ...

4. haematologica.org haematologica.org/article/view/haematol.2024.284967

Oral iron supplementation: new formulations, old questions An optimal response to oral iron therapy is expected to increase hemoglobin by 2 g/dL within 3-4 weeks., A hemoglobin increase of 1 g/dL within ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0098299720300364

Oral iron supplementation in iron-deficient women Oral iron supplementation can be an effective strategy to treat and prevent IDA, but guidelines vary. Some experts recommend doses of 150–200 mg elemental iron ...

6. drugs.com drugs.com/ferrous_sulfate.html

Ferrous Sulfate: Uses, Dosage & Side Effects Ferrous sulfate is used to treat iron deficiency anemia. Includes ferrous sulfate side effects, interactions and indications.

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Iron%20-HealthProfessional/

Iron - Health Professional Fact Sheet Iron overview for health professionals. Research health effects, dosing, sources, deficiency symptoms, side effects, and interactions here.

8. laballey.com laballey.com/blogs/articles/ferrous-sulfate-overview?srsltid=AfmBOorJShDTXLlmOBO0boX9tH0VjUtipuCjTlVdu9LbJaLP_HhiQyXa

Ferrous Sulfate Overview: Properties, Applications, Safety ... Ferrous sulfate can irritate skin, eyes, and the respiratory system upon direct contact or inhalation of dust particles. Ingestion of large ...

9. go.drugbank.com go.drugbank.com/drugs/DB13257

Ferrous sulfate: Uses, Interactions, Mechanism of Action Ferrous sulfate is a synthetic agent used in the treatment of iron deficiency. It is the gold standard of oral iron therapy in the UK and many other countries.