Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
FEMALE
Healthy Volunteers
NCT06942208

Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35

Led by University of Calgary · Updated on 2026-04-17

36

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

M

Mitacs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35

Who Can Participate

Age: 16Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biologically female athlete
  • Age 16-35 years
  • 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 Tier 3 (Highly Trained / National Level) or Tier 4 (Elite / International Level) based on Participant Classification Framework
  • Energy availability >30 kcal/kg lean body mass
  • Have access to a smartphone, tablet, or computer
  • Able to swallow a capsule sized 25mm length and 8mm width
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Anemic (hemoglobin <120 g/L)
  • Regular use of prebiotics or probiotics within 4 weeks before study
  • Current laxative use
  • Smoker or tobacco user
  • Consume more than 21 units of alcohol per week
  • Blood donation within the previous 3 months
  • BMI less than 16 or greater than 30 kg/m2
  • Dieting for weight loss or following a low carbohydrate diet
  • Participation in another clinical trial within 30 days prior to enrollment
  • Known allergy or hypersensitivity to iron, yeast, cellulose, maltodextrin, or other ingredients
  • Taking medications affecting cardiovascular or metabolic exercise responses (e.g., beta-blockers, anti-coagulants)
  • Known history of thalassemia or thalassemia trait
  • Known inherited bleeding disorder
  • Major surgery in past 3 months
  • Chronic use of salicylates, aspirin, corticosteroids, or nonsteroidal anti-inflammatory drugs
  • Having renal, gastrointestinal, autoimmune, metabolic, heart, vascular, rheumatoid arthritis, diabetes, lung, thyroid, or other significant health conditions affecting study participation
  • Current musculoskeletal injuries limiting exercise
  • Orthopaedic issues limiting exercise ability
  • Taking prescription medications affecting iron absorption within past 3 months
  • Taking levodopa or levothyroxine
  • Taking iron-containing supplements currently or within past 3 months
  • Pregnant, lactating, or planning pregnancy during study; must use approved birth control with minimum 3 months prior use
  • History of gastrointestinal disease, surgery, or radiation that may cause intestinal obstruction or capsule retention
  • Structural gastrointestinal abnormalities causing obstruction
  • Gastrointestinal inflammatory diseases (e.g., ulcerative colitis, Crohn's disease)
  • Use of medications altering gastrointestinal motor function recently
  • Antibiotic use within past 12 weeks
  • Regular use of probiotics, prebiotics, or synbiotics
  • Digestive problems slowing food movement
  • Celiac disease
  • Organic motility disorders
  • History of swallowing disorders increasing capsule aspiration risk
  • Cancer diagnosis or treatment within past year except non-melanoma skin cancers
  • Difficulty swallowing risking capsule choking
  • Scheduled for MRI during study
  • Constant constipation (IBS-C) with less than 3 bowel movements per week
  • Prior fecal microbiota transplantation
  • Drug or alcohol abuse
  • Uncertain or likely pregnancy without confirmation and agreement to stop if pregnant
  • Not allowed to change or add supplements unless medically recommended during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

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Research Team

L

Lauren Hundseth

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35 | DecenTrialz