Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
FEMALE
Healthy Volunteers
ID06942208

Iron Revisited: Alternate-Day Oral Iron Supplementation in Endurance, Intermittent, and Power/Strength Female Athletes Aged 16-35

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

36

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

M

Mitacs

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how different types and doses of oral iron supplements affect iron levels, athletic performance, and gut health in young female athletes with low iron stores. The trial compares a low-dose iron supplement, a low-dose yeast-bound iron supplement, and a high-dose iron supplement to find which works best and causes fewer stomach issues. This research focuses on female athletes aged 16 to 35 who have suboptimal ferritin levels and are competitively trained. Participants will be randomly assigned to take one of the three iron supplements every other day for 12 weeks. The supplements are encapsulated to keep the study blinded and include a low-dose ferrous sulfate, a low-dose yeast-bound iron (Lalmin® Fe10), and a high-dose ferrous sulfate. They will take the supplement within 30 minutes of morning training or upon waking if no morning training occurs. Follow-up visits occur at 4 and 8 weeks for blood tests and food logs, and participants will complete fitness tests before and after the intervention. During the study, participants will have six in-person visits for screenings, fitness assessments, and sample collections including blood, stool, and small intestine samples using SIMBA capsules. They will complete regular online surveys about sleep, stress, menstrual cycles, and gut symptoms. Researchers will measure changes in iron blood markers, gut bacteria, aerobic and anaerobic performance, body composition, and gastrointestinal health. Safety and supplement adherence will be monitored throughout the trial, which lasts about 12 weeks plus screening and follow-up assessments.

CONDITIONS

Brief 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 between 16 and 35 years
  • At least one year after first menstrual period (menarche)
  • Complete and pass the Get Active Questionnaire
  • Suboptimal ferritin level (≤50 mcg/L)
  • Provide informed consent
  • Competitively trained at highly trained or elite level
  • Energy availability greater than 30 kcal/kg lean body mass
  • Have access to a smartphone, tablet, or computer
  • Able to swallow a capsule measuring 25mm by 8mm
Not Eligible

You will not qualify if you...

  • Non-English speaking
  • Anemia with hemoglobin less than 120 g/L
  • Using prebiotics or probiotics regularly within 4 weeks before enrollment
  • Current use of laxatives
  • Smoking or tobacco use
  • Consuming more than 21 units of alcohol per week
  • Donated blood within the last 3 months
  • Body mass index 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
  • Known allergy or hypersensitivity to iron, yeast, cellulose, or maltodextrin
  • Taking medications affecting cardiovascular or metabolic responses to exercise
  • History of thalassemia or inherited bleeding disorders
  • Major surgery within past 3 months
  • Chronic use of salicylates, aspirin, corticosteroids, or NSAIDs
  • Having kidney, gastrointestinal, autoimmune, metabolic, heart, vascular, rheumatoid arthritis, diabetes, lung, thyroid, or other significant health conditions
  • Current musculoskeletal injuries limiting exercise
  • Orthopaedic issues limiting exercise ability
  • Taking prescription medications affecting iron absorption
  • Taking levodopa or levothyroxine
  • Taking iron supplements currently or within last 3 months
  • Pregnant, lactating, or planning pregnancy during study
  • Not using approved birth control methods
  • History of gastrointestinal diseases or surgeries affecting capsule passage
  • Use of antibiotics within 12 weeks prior
  • Constant constipation or digestive motility disorders
  • History of cancer diagnosis or treatment within past year (except non-melanoma skin cancer)
  • Swallowing disorders or risk of capsule choking
  • Scheduled for MRI during study
  • Drug or alcohol abuse
  • Other conditions judged to interfere with study by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Baseline Testing

Duration - 1 week

Participants complete initial assessments including blood tests for iron status, body composition, aerobic and anaerobic fitness tests, and provide fecal samples before starting supplementation.

2 visits (in-person) within one week

Treatment

Duration - 12 weeks

Participants consume an oral iron supplement every other day for 12 weeks, while completing weekly online questionnaires on gastrointestinal symptoms and recovery. They return to the lab at weeks 4 and 8 for blood tests and food logs, and receive additional supplement supplies.

6 visits (in-person) including weeks 4 and 8 follow-ups and end-of-treatment assessments; weekly online surveys

Post-Intervention Testing

Duration - 1 week

After completing the 12-week supplementation, participants return for repeat assessments of iron status, body composition, fitness tests, dietary intake, and fecal sample collection to evaluate the effects of the intervention.

2 visits (in-person) within one week

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

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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