Iron Supplement for Iron Deficiency

Overseen By Keely Shaw, Ph.D.

Age: 18 - 65

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 if it helps female endurance athletes with low iron levels improve their iron status, gut health, and exercise performance. Low iron can hinder exercise performance, so the research seeks better ways to support these athletes. Women who have engaged in endurance activities like running or cycling for at least 3 hours a week and have low iron (ferritin of 45 or less) may be suitable for this study. Participants should not have recently taken iron, prebiotic, or probiotic supplements. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance athletic performance and overall health.

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

The trial does not specify if you need to stop taking your current medications, but you cannot have taken iron supplements, prebiotics, probiotics, or antibiotics 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 FeSC (iron-yeast complex) supplement is generally easy for people to tolerate. In earlier studies, active women who took FeSC reported only a few side effects. Some experienced mild stomach issues, but these were not serious. Researchers also tested the supplement in a fortified cookie, which participants similarly tolerated well. Overall, the evidence suggests that FeSC is safe to use, especially for active individuals like endurance athletes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard iron supplements for iron deficiency, which often include ferrous sulfate or ferrous gluconate, FeSC is an iron/yeast complex that offers a unique approach. Researchers are excited about FeSC because it potentially enhances iron absorption and reduces gastrointestinal side effects, a common issue with traditional iron pills. This novel formulation could make iron supplementation more tolerable and effective for individuals who struggle with the typical side effects of existing treatments.

What evidence suggests that this iron supplement could be effective for iron deficiency?

Research has shown that FeSC, the investigational iron supplement in this trial, can improve iron levels in female athletes. Iron deficiency is common in this group and often leads to tiredness and poor performance. Studies have found that FeSC is gentle on the stomach and might aid digestion, making it a promising option. Several trials have tested the supplement, consistently demonstrating its ability to improve iron levels and potentially enhance exercise performance. While more research is needed, early results are positive for those facing iron deficiency. ^{1 3 4 6 7}

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 18-25 with low iron levels (ferritin ≤45mcg/L). Participants should be at least one year past menarche and actively engage in endurance activities for a minimum of three hours weekly.

Inclusion Criteria

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

I have had my first menstrual period over a year ago.

I exercise for 3 hours a week with activities like running or swimming.

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. Weekly surveys are conducted to report stress, recovery, and gastrointestinal symptoms.

8 weeks

Weekly surveys (virtual)

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 is testing FeSC, a new iron supplement, to see if it can improve iron status, benefit the gut microbiome, and enhance exercise performance in 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

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]

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.

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.

doaj.org

doaj.org/article/55caaaf4c1a74eb1a845062944635c9b

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 benefits.

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.

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 ...

5.

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 ...

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.

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.