Iron Supplements for Iron Deficiency

Overseen By Lauren Hundseth

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Antibiotics, Antacids, NSAIDs, others

Disqualifiers: Anemia, Smoking, Alcohol, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

36 Participants Needed

Trial Summary

Is it safe to take iron supplements like ferrous sulfate?

Iron supplements, such as ferrous sulfate, can have side effects like diarrhea, increased risk of infections, and gut inflammation. However, some forms of iron, like iron amino acid chelates, are considered safe by the US-FDA when used properly. ^{1 2}

How does the drug 'Iron Supplements for Iron Deficiency' differ from other treatments for iron deficiency?

This drug uses different doses of ferrous sulfate, including a yeast-bound form, which may offer higher bioavailability (how well the body can use the iron) and potentially fewer side effects compared to standard ferrous iron salts, making it a unique option for treating iron deficiency. ^{3 4 5 6 7}

What is the purpose of this trial?

The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are: * Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements? * Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms? * How do iron supplements affect exercise performance and gut bacteria? Researchers will compare three types of iron supplements: * A low-dose iron supplement (40 mg) * A low-dose yeast-bound iron supplement (40 mg) * A high-dose iron supplement (150 mg) This will help researchers find out which type of supplement is most effective and easiest on the stomach. Participants will: * Take one of the three assigned iron supplements every other day for 12 weeks * Complete fitness tests before and after the study, including cycling and jumping tests * Give blood samples to measure iron levels * Provide stool and intestinal samples to study gut bacteria * Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine * Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms

Research Team

Jane Shearer

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for young female athletes aged 16-35 who have low iron stores, potentially affecting their performance. They must be willing to take iron supplements, undergo fitness tests, and provide blood, stool, and intestinal samples. Athletes should not participate if they have conditions that could interfere with the study or are unable to comply with its requirements.

Inclusion Criteria

Complete and pass the Get Active Questionnaire (GAQ)

Suboptimal ferritin levels (≤50 mcg/L)

Provide informed consent to participate in study

Exclusion Criteria

I am currently using laxatives.

My BMI is between 16 and 30.

I have been taking iron supplements in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing including blood draw, DXA scan, VO2 max test, and anaerobic performance testing

1 week

2 visits (in-person)

Treatment

Participants take assigned iron supplements every other day for 12 weeks and complete regular surveys

12 weeks

1 visit (in-person) every 4 weeks

Follow-Up

Participants are monitored for changes in iron status, gut microbiota, and athletic performance

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• High-dose iron (ferrous sulfate)
• Low-dose iron (ferrous sulfate)
• Yeast-bound iron (ferrous sulfate)

Trial Overview The trial is testing three types of oral iron supplements: a high-dose (150 mg), a low-dose (40 mg), and a low-dose yeast-bound version (40 mg). It aims to determine which improves iron levels and athletic performance while being gentle on the gut over a period of 12 weeks.

Participant Groups

Group I: Low dose iron supplement bound to yeast Experimental Treatment 1 Intervention

Low dose iron (40 mg elemental iron) in the form of yeast-bound iron, specifically Lalmin® Fe10. This supplement consists of encapsulated ferrous sulphate complexed with inactivated Saccharomyces cerevisiae (nutritional yeast).

Group II: Low dose iron supplement Active Control 1 Intervention

This supplement consists of encapsulated ferrous sulphate (40 mg elemental iron).

Group III: High dose iron supplement Active Control 1 Intervention

This supplement consists of encapsulated ferrous sulphate (150 mg elemental iron).

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials

63

Recruited

3,000+

Findings from Research

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]

In a 12-week study involving 72 participants with uncomplicated iron deficiency anemia, a ferrous iron supplement (Ferall) was found to be significantly more effective than a ferric iron polysaccharide complex (Niferex) in improving hemoglobin and serum ferritin levels.

While the ferrous product was associated with a slightly higher frequency of gastrointestinal side effects, both supplements were well tolerated, and no participants withdrew due to side effects, indicating that the ferrous product is safe and effective for treating iron deficiency anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: a Taiwanese study. Liu, TC., Lin, SF., Chang, CS., et al.[2019]

Ferrous salts, specifically ferrous fumarate, gluconate, and sulfate, are commonly used and well-tolerated oral treatments for iron deficiency anemia, which is a frequent health issue.

Mössbauer spectroscopy and X-ray powder diffraction techniques were used to analyze these ferrous salts, revealing that ferrous fumarate and gluconate contain about 10% ferric iron, and providing the first reported Mössbauer spectrum for ferrous fumarate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mössbauer and X-ray powder diffraction study of some ferrous hematinics. Coe, EM., Bowen, LH., Bereman, RD.[2019]

References

1. United States 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. [2022]

2. United States 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. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Comparison of a combination ferrous fumarate product and a polysaccharide iron complex as oral treatments of iron deficiency anemia: a Taiwanese study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Mössbauer and X-ray powder diffraction study of some ferrous hematinics. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Iron bioavailability from commercially available iron supplements. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison study of oral iron preparations using a human intestinal model. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Influence of high dietary iron as ferrous carbonate and ferrous sulfate on iron metabolism in young calves. [2014]