The goal of this clinical trial is to learn whether oral iron supplementation will increase skeletal muscle iron storage and its effects on exercise capacity in females with suboptimal iron status. The study will include healthy females, ages 18-40, who either have suboptimal or optimal iron stores.
The main questions it aims to answer are:
* Does iron supplementation increase skeletal muscle iron storage and alter the expression of iron-related and mitochondrial proteins?
* Does iron supplementation improve single-leg exercise performance?
* Is serum ferritin correlated with the abundance of iron-related proteins in skeletal muscle?
Researchers will compare outcomes from females with suboptimal iron status who receive oral iron supplementation to those who receive a placebo to see if supplementation improves muscle iron storage, protein expression, and exercise performance. Additionally, a non-intervention control group with optimal iron status will be included to assess baseline differences.
Participants will:
\- Be randomly assigned to receive 150 mg elemental iron or placebo (maltodextrin) every other day for 12 weeks
Complete pre- and post-supplementation testing, including:
* Blood draws to assess iron status
* Skeletal muscle biopsies to analyze protein content
* Whole-body and single-leg exercise tests to assess performance
* Controls will undergo baseline-only testing to compare physiological and biochemical markers
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* biologically female
* between the ages of 18-40 years of age at the time of enrolment
* plasma ferritin ≤ 50 µg/ L (RCT) or \>50 µg/L (controls)
* complete Get Active Questionnaire (GAQ: Canadian Society for Exercise Physiology) without contraindication
Exclusion Criteria:
* have a body mass index (BMI) \> 30 kg/m2
* taking medications that have been shown to affect cardiovascular, respiratory, or metabolic responses to exercise (e.g., β-blockers, anti-inflammatories, anti-coagulants, insulin, etc.)
* hemoglobin ≤ 120 g/L (anemia cut-off for women)
* have known health problems or contraindications that prohibit exercise, including renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, arthritis, diabetes, respiratory disease, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions that are being treated and deemed likely to confound the results
* dieting for weight loss or following a low-carbohydrate diet (known to affect iron homeostasis)
* history of smoking or using tobacco products
* consuming excessive amounts of alcohol (\>21 units/week)
* supplementing with iron (\>5mg/day) in the last 3 months
* any blood donation or surgeries in the past 3 months
* antibiotic use within the previous four weeks before study enrolment
* current laxative use
* known history of thalassemia
* known bleeding disorder
* chronic use of nonsteroidal anti-inflammatory drugs
* Currently/last 3 months taking prescription medications that are known to affect iron absorption (i.e. Antacids/PPIs (e.g., omeprazole), H2 Blockers (e.g., ranitidine), Tetracycline Antibiotics (e.g., doxycycline), Quinolone Antibiotics (e.g., ciprofloxacin), Cholestyramine, Colchicine, Methyldopa).
* currently pregnant or plans to get pregnant within the duration of the study, and
* do not understand English
* Participants will be removed from the study if they begin taking any other forms of supplemental iron or choose to donate blood
Primary outcome measure(s)
Muscle Ferritin — At baseline (week 0) and completion of supplementation (week 12) Muscle collection: The muscle biopsy involves the removal of a small piece of muscle tissue from the vastus lateralis using a sterile hollow needle. The area over the incision site will be carefully cleaned, and a small amount of local anesthetic will be injected into and under the skin. A small, 4 - 5 mm incision will be made in the skin to create an opening for the biopsy needle.
The biopsy needle will then be inserted through the incision into the muscle, and a small piece of muscle (\~50 mg) will be removed, and the needle taken out. A medical doctor will perform this procedure.
Protein analysis: Western blotting will be used to analyze the abundance of ferritin within small sections of the muscle sample.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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