Oral iron supplementation: new formulations, old questions.
Kostas Pantopoulos
https://pubmed.ncbi.nlm.nih.gov/38618666Actively Recruiting
Led by University of Calgary · Updated on 2026-04-17
36
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Calgary
Lead Sponsor
M
Mitacs
Collaborating Sponsor
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
Improving Iron Levels in Female Endurance, Intermittent, and Power/Strength Athletes Aged 16-35
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
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
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
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
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
L
Lauren Hundseth
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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