Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35 (NCT06942208) | Clinical Trial Compass
RecruitingNot Applicable
Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35
Canada36 participantsStarted 2026-03-26
Plain-language summary
The goal of this clinical trial is to learn if different types and doses of oral iron supplements can improve iron levels, athletic performance, and gut health in young female athletes with low iron stores. The main questions it aims to answer are:
* Does a low dose of yeast-bound iron improve iron status better than traditional iron supplements?
* Do the different iron supplements cause fewer or more gastrointestinal (stomach) symptoms?
* How do iron supplements affect exercise performance and gut bacteria?
Researchers will compare three types of iron supplements:
* A low-dose iron supplement (40 mg)
* A low-dose yeast-bound iron supplement (40 mg)
* A high-dose iron supplement (150 mg)
This will help researchers find out which type of supplement is most effective and easiest on the stomach.
Participants will:
* Take one of the three assigned iron supplements every other day for 12 weeks
* Complete fitness tests before and after the study, including cycling and jumping tests
* Give blood samples to measure iron levels
* Provide stool and intestinal samples to study gut bacteria
* Swallow a SIMBA capsule before and after the study to collect a sample from the small intestine
* Complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms
Who can participate
Age range
16 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biologically female athlete
* Age 16-35
* At least one year past the age of menarche
* Complete and pass the Get Active Questionnaire (GAQ)
* Suboptimal ferritin levels (≤50 mcg/L)
* Provide informed consent to participate in study
* Activity level based on Participant Classification Framework (McKay et al., 2022)
* Tier 3: Highly Trained / National Level
* Tier 4: Elite / International Level
* Energy availability \>30 kcal/kg LBM
* Have access to a smartphone, tablet, or computer
* Able to swallow a capsule sized 25mm length and 8mm width (i.e. large dose omega 3 pill)
Exclusion Criteria:
* Non-English speaking
* Anemic (hemoglobin \<120g/L)
* Regular prebiotic (fiber) or probiotic use within 4 weeks of study enrollment
* Current laxative use
* Are a smoker or use tobacco products
* Consume \>21 units of alcohol per week
* Have donated blood in the previous 3 months
* Have a BMI \<16 but \>30kg/m2
* Are dieting for weight loss or are following a low carbohydrate diet
* Have participated in another clinical trial within the 30 days preceding study enrollment.
* Known allergy of hypersensitivity to any ingredient, including non-medicinal ingredients, such as iron, yeast, cellulose, or maltodextrin
* Are taking medications known to affect cardiovascular or metabolic responses to exercise such as beta-blockers, anti-coagulants etc. as assessed by the Principal Investigator
* Known history of thalassemia or thalassemia trait
* Known inherited bleedin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.