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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Is the iron supplement safe for humans?

Research shows that various forms of iron supplements, including iron-protein-succinylate and a novel iron syrup, are generally safe and well-tolerated in humans, with fewer side effects compared to traditional iron supplements like ferrous sulfate. Common side effects, when they occur, include mild digestive issues such as heartburn and constipation. ¹

How does the drug FeSC differ from other iron supplements for iron deficiency?

FeSC may offer a unique approach by potentially allowing for less frequent dosing, which can minimize side effects and improve adherence compared to daily iron supplements. This approach aligns with findings that intermittent iron supplementation can be as effective as daily dosing while reducing oxidative stress and side effects. ^{2 3 4 5 6}

Research Team

Jane Shearer, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. 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]

2. Venezuela pubmed.ncbi.nlm.nih.gov

Iron supplementation as a strategy for the control of iron deficiency and ferropenic anemia. [2021]

3. Germany 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Adverse effect of iron supplementation on weight gain of iron-replete young children. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of various iron-supplementation regimens in improving the Fe status of anaemic rats. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Efficacy of polysaccharide iron complex in IDA rats: A comparative study with iron protein succinylate and ferrous succinate. [2023]