Iron Supplement for Iron Deficiency
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.12345
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.13467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume 40mg of elemental iron every second day for 8 weeks. Weekly surveys are conducted to report stress, recovery, and gastrointestinal symptoms.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of iron status, gut microbiome, and exercise capacity.
What Are the Treatments Tested in This Trial?
Interventions
- FeSC
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Natural Sciences and Engineering Research Council, Canada
Collaborator
Mitacs
Industry Sponsor