Iron Supplementation for Iron Deficiency

(MyoIRON Trial)

Overseen By Alexander L Isidori

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Calgary

Must not be taking: Beta-blockers, Antacids, NSAIDs, others

Disqualifiers: Anemia, BMI > 30, Diabetes, others

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether oral iron supplements can boost muscle iron levels and enhance exercise performance in women with low iron. Researchers aim to determine if these supplements can increase iron storage in muscles and improve muscle function during exercise. Women with low iron levels who are otherwise healthy might be suitable candidates. Participants will take either an iron supplement or a placebo (a sugar pill) to compare effects over 12 weeks. As an Early Phase 1 trial, this study focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking certain medications that affect cardiovascular, respiratory, or metabolic responses to exercise, as well as those that affect iron absorption, such as antacids, PPIs, and certain antibiotics.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that oral iron supplements, such as ferrous sulfate, are commonly used to treat iron deficiency anemia by increasing iron levels in the body. Most people tolerate these supplements well, though some may experience side effects. Common issues include stomach problems, such as nausea and constipation, which are usually mild and temporary. The treatment in this trial is in its early stages, so researchers are still gathering safety information specific to this use. However, the widespread use of ferrous sulfate for other iron deficiencies suggests it is generally safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for iron deficiency involve dietary changes or intravenous iron infusions. But this new oral iron supplement, encapsulated ferrous sulfate, stands out because it provides a hefty 150mg of elemental iron per dose, which could be more effective at quickly boosting iron levels. Researchers are excited because this oral delivery method is less invasive and more convenient than IV infusions, potentially improving patient compliance and comfort. Additionally, the encapsulation technology may enhance absorption and reduce gastrointestinal side effects, making it a promising option for those who struggle with traditional iron supplements.

What evidence suggests that oral iron supplementation could be effective for improving exercise capacity in females with suboptimal iron status?

Research shows that oral iron pills can effectively treat low iron levels, known as iron deficiency anemia. This trial will test an oral iron supplement, specifically encapsulated ferrous sulfate, against a placebo. One study found that ferrous sulfate was about 86.7% effective in helping children with this condition. For women with low iron, these supplements can boost iron levels and help prevent future shortages. Taking iron pills every other day can also enhance iron absorption. While most research focuses on anemia, increased iron might also improve muscle strength and exercise performance. ^{4 6 7 8 9}

Who Is on the Research Team?

Martin J MacInnis

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for healthy females aged 18-40 with suboptimal iron stores, indicated by a plasma ferritin level of ≤50 µg/L. They must complete a Get Active Questionnaire without contraindications to participate. Women with optimal iron levels (ferritin >50 µg/L) can join as non-intervention controls.

Inclusion Criteria

I completed the Get Active Questionnaire without any issues.

My plasma ferritin level is either ≤ 50 µg/L or > 50 µg/L.

I am biologically female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

5 visits (in-person)

Baseline Testing

Participants undergo baseline testing including blood draw, body composition scan, exercise tests, and muscle biopsy

2 weeks

5 visits (in-person)

Supplementation

Participants receive either iron supplementation or placebo every other day for 12 weeks

12 weeks

2 visits (in-person) for blood draws at weeks 4 and 8

Post-supplementation Testing

Participants undergo post-supplementation testing including blood draw, muscle biopsy, body composition scan, and exercise tests

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral iron supplement

Trial Overview The study tests if oral iron supplements increase muscle iron storage and improve exercise performance in women with low iron. Participants will either receive an oral iron supplement or placebo every other day for 12 weeks, alongside pre- and post-supplementation testing including blood draws, muscle biopsies, and exercise tests.

How Is the Trial Designed?

Group I: Iron supplement Experimental Treatment 1 Intervention

Dietary supplement: Oral iron supplement, encapsulated ferrous sulphate (150mg elemental iron)

Group II: Placebo Placebo Group 1 Intervention

Placebo control: Sugar pill, encapsulated polysaccharide substance (malodextrin)

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

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

Oral iron supplementation: new formulations, old questions Oral iron supplementation is usually efficacious in correcting iron deficiency anemia and replenishing iron stores but causes gastrointestinal side effects ...

3. 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 ...

4. nature.com nature.com/articles/s41598-023-29034-9

Alternate day versus daily oral iron for treatment of ... Oral iron is the mainstay of treating iron deficiency anemia. Recent studies indicate better fractional iron absorption with alternate day ...

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

Optimal Oral Iron Therapy for Iron Deficiency Anemia ... In this cohort study, all different oral iron strategies improved hemoglobin and iron indices but at slower paces in alternate day dosing.

6. 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.

7. 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.

8. 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.

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

Iron Deficiency Anemia Treatment & Management British Society of Gastroenterology guidelines recommend starting treatment of iron deficiency anemia with one tablet of ferrous sulfate, ...