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NCT07084298

EARLY_PHASE1

Effects of Iron Supplementation on Skeletal Muscle Properties in Females With Suboptimal Iron Storage

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

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

Official title: Effects of 12 Weeks of Oral Iron Supplementation on Skeletal Muscle Iron Content, Mitochondrial Function, and Indices of Aerobic Fitness in Healthy Females With Suboptimal Iron Stores

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08

Completion Date

2026-06

Last Updated

2025-08-06

Healthy Volunteers

Yes

Conditions

Iron Deficiency

Interventions

DIETARY_SUPPLEMENT

Oral iron supplement

Encapsulated ferrous sulphate (150mg elemental iron)

OTHER

Placebo

Encapsulated polysaccharide (maltodextrin)

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

Locations (1)

University of Calgary

Calgary, Alberta, Canada