Iron Supplement for Iron Deficiency

Overseen By Keely Shaw, PhD

Age: < 18

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Iron supplements, Prebiotics, Probiotics, Antibiotics

Disqualifiers: High energy availability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new iron supplement (FeSC) to determine its effects on iron levels, gut health, and exercise performance in female endurance athletes. It seeks cis-gendered females aged 14-18 with low iron levels who have been menstruating for at least a year and regularly engage in endurance activities like running or cycling for 3 or more hours a week. Participants should not have recently taken iron supplements, prebiotics, or probiotics. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance athletic performance and overall health.

Do 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've taken iron supplements, prebiotics, or probiotics in the last 3 months.

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

Research has shown that the iron supplement FeSC is usually easy for people to take. In studies, most participants using FeSC experienced few side effects. These studies included active women, similar to those who might join this trial. While some individuals experienced mild stomach problems, this was uncommon. Overall, current research suggests that FeSC is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike current treatments for iron deficiency, which often rely on traditional iron salts like ferrous sulfate, the iron/yeast complex (FeSC) is unique because it combines iron with yeast to enhance absorption and reduce gastrointestinal side effects. Researchers are excited about FeSC because its innovative formulation could improve how the body absorbs iron, potentially offering a more effective and gentler alternative for people who struggle with traditional iron supplements. This approach could mean fewer stomach issues, like constipation or nausea, which are common complaints with standard iron pills.

What evidence suggests that this treatment might be an effective treatment for iron deficiency?

Research has shown that many female athletes often lack sufficient iron, leading to fatigue and decreased performance. Studies have found that iron in yeast, such as the FeSC supplement tested in this trial, might be absorbed better by the body than regular iron. Animal studies suggested it could be more effective in treating anemia. This supplement aims to boost iron levels, improve gut health, and enhance exercise performance in endurance athletes. Although research on humans is ongoing, these early results indicate it could be a promising method to improve athletic performance by addressing iron deficiency. ^{1 3 6 7 8}

Who Is on the Research Team?

Jane Shearer, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for cis-gendered female athletes aged 14-18 with low iron levels (ferritin ≤45mcg/L) who are at least one year past menarche and do moderate to vigorous endurance activities for a minimum of three hours weekly.

Inclusion Criteria

I exercise vigorously for 3 hours or more each week.

My iron levels are low (ferritin ≤45mcg/L).

I am a cisgender female aged between 14 and 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 40mg of elemental iron every second day for 8 weeks and complete weekly surveys on stress, recovery, and gastrointestinal symptoms.

8 weeks

Weekly surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of iron status, gut microbiome, and exercise capacity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FeSC

Trial Overview

The study tests the effectiveness of a new iron supplement, FeSC, on improving iron status, gut health, and exercise performance in young female endurance athletes with iron deficiency.

How Is the Trial Designed?

Group I: Iron/yeast complex (FeSC) Experimental Treatment 1 Intervention

Iron Supplement

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+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Published Research Related to This Trial

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 80 pregnant women, ferrous bisglycinate (25 mg iron/day) was found to be as effective as ferrous sulfate (50 mg iron/day) in preventing iron deficiency and iron deficiency anemia during pregnancy.

Ferrous bisglycinate resulted in fewer gastrointestinal complaints compared to ferrous sulfate, making it a potentially safer option for iron supplementation in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferrous bisglycinate 25 mg iron is as effective as ferrous sulfate 50 mg iron in the prophylaxis of iron deficiency and anemia during pregnancy in a randomized trial. Milman, N., Jønsson, L., Dyre, P., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12357401/

Exploring tolerance and side effects of an innovative yeast ...

Iron deficiency is prevalent among female athletes, often leading to fatigue, impaired recovery, and decreased performance.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11255036/

Production of iron-enriched yeast and it's application in the ...

The aim of this study was to investigate the effect of S. cerevisiae enriched iron as a potential organic iron supplement on mice with iron deficiency anemia.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06942208

Improving Iron Levels in Female Endurance, Intermittent ...

This clinical trial is designed to evaluate and compare the effects of three oral iron supplementation strategies on iron status, gut microbiota, and athletic ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06338787

A Novel Iron-Based Supplement for Athletes Aged 14-17

This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained ...

5.

nature.com

nature.com/articles/s41598-024-55433-7

Production of iron enriched Saccharomyces boulardii

Animal studies have shown that organic iron produced in yeast has a greater potential to absorb and improve anemia than the inorganic form. The ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40817080/

Exploring tolerance and side effects of an innovative yeast ...

Conclusions: This study demonstrates the feasibility and tolerability of FeSC supplementation in active females, with potential gastrointestinal ...

7.

researchgate.net

researchgate.net/publication/394502157_Exploring_tolerance_and_side_effects_of_an_innovative_yeast-bound_iron_supplement_a_feasibility_trial

(PDF) Exploring tolerance and side effects of an innovative ...

This feasibility trial investigated the tolerability and gastrointestinal effects of an iron-yeast complex (FeSC) supplement in physically active females to ...

8.

link.springer.com

link.springer.com/article/10.1007/s10534-024-00592-3

Production of iron-enriched yeast and it's application in the ...

The aim of this study was to investigate the effect of S. cerevisiae enriched iron as a potential organic iron supplement on mice with iron deficiency anemia.