Iron DeficienciesNCT06269913
A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II
A study testing FeSC in people with Iron Deficiencies, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- FeSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- cis-gendered female 18-25years old
- sub-optimal iron status (ferritin ≤45mcg/ L)
- At least 1 year past the age of menarche
- Engage in moderate to vigorous endurance activity for at least 3 hours a week
Who cannot join
- Supplemented with iron iron (>5mg/day), prebiotics, or probiotics in last 3 months
- antibiotic use in last 3 months
- - Energy availability >30 kcal/kg lean body mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
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.
Read the detailed description
Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.
- Conditions
- Iron Deficiencies
- Being tested
- FeSC
- Keywords
- iron, microbiota, endurance. exercise
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeSCOther
Iron/yeast complex
| Study group | Role | What they receive |
|---|---|---|
| Iron/yeast complex (FeSC) | Experimental | Iron Supplement Receives: Other: FeSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Status
Ferritin
Measured: 4 weeks, 8 weeks
Hemoglobin
Hemoglobin concentration
Measured: 4 weeks, 8 weeks
Upper Gut Microbiome
SIMBA capsule
Measured: 4 weeks, 8 weeks
Lower Gut microbiome
Fecal sample
Measured: 4 weeks, 8 weeks
Secondary outcomes (3)
Exercise Capacity
Oxygen Consumption (VO2max)
Measured: 8 weeks
Hemoglobin Mass
Carbon monoxide Rebreathing Technique
Measured: 8 weeks
Gastrointestinal Symptoms 1
Gastrointestinal Symptoms Questionnaire
Measured: Weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start17 Jun 2024
- Primary completion12 Mar 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Jane Shearer, University of Calgary
- Investigators
- Jane Shearer, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269913
- Sponsor's protocol ID
- 23-0826
- Status last verified
- May 2025
- First submitted
- 12 Feb 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
- ClinicalTrials.gov ID
- NCT06269913
- Acronym / sponsor ID
- 23-0826
- Conditions
- Iron Deficiencies
- Keywords
- iron, microbiota, endurance. exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Mitacs, Natural Sciences and Engineering Research Council, Canada
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron/yeast complex (FeSC) | Experimental | Other: FeSCIron Supplement |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- cis-gendered female 18-25years old
- sub-optimal iron status (ferritin ≤45mcg/ L)
- At least 1 year past the age of menarche
- Engage in moderate to vigorous endurance activity for at least 3 hours a week
Key exclusion criteria (3 listed)
- Supplemented with iron iron (>5mg/day), prebiotics, or probiotics in last 3 months
- antibiotic use in last 3 months
- - Energy availability >30 kcal/kg lean body mass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeSCIron/yeast complex | Other | Iron/yeast complex (FeSC) |
Primary outcome
Iron Status
Time frame: 4 weeks, 8 weeks
Ferritin
Hemoglobin
Time frame: 4 weeks, 8 weeks
Hemoglobin concentration
Upper Gut Microbiome
Time frame: 4 weeks, 8 weeks
SIMBA capsule
Lower Gut microbiome
Time frame: 4 weeks, 8 weeks
Fecal sample
3 secondary outcomes
Exercise Capacity
Time frame: 8 weeks
Hemoglobin Mass
Time frame: 8 weeks
Gastrointestinal Symptoms 1
Time frame: Weekly for 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Shearer, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeSC in people with Iron Deficiencies, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron Status (time frame: 4 weeks, 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.