Lactoferrin-Iron Trial Targets Low Ferritin in Exercising Women
ClinicalTrials.gov Studies
Summary
A randomized, double-blind, active-controlled pilot trial registered on ClinicalTrials.gov will evaluate whether oral lactoferrin supplementation (100 mg or 300 mg daily) combined with low-dose iron (5 mg) improves iron status and exercise performance in exercising women aged 18-45 years with serum ferritin below 35 µg/L. Approximately 30 participants will be enrolled for an 8-week intervention, with primary outcomes measuring changes in ferritin and hematological parameters and secondary outcomes including VO₂peak, time to exhaustion, and lactate responses during standardized treadmill testing. The study aims to determine whether lactoferrin enhances iron homeostasis and physiological performance outcomes in women with low iron stores.
“This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin.”
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What changed
This ClinicalTrials.gov registry entry documents a new pilot study evaluating the effects of human lactoferrin supplementation at two dose levels (100 mg and 300 mg) combined with 5 mg iron versus placebo plus iron on iron homeostasis and exercise performance in exercising women with low ferritin. Participants (approximately 30) will be enrolled for 8 weeks and stratified by baseline ferritin status, with primary outcomes including ferritin and hematological changes and secondary outcomes including aerobic performance metrics during treadmill testing.
The trial is an informational registration rather than a regulatory action and does not impose compliance obligations on any party. Healthcare researchers conducting iron supplementation or exercise performance studies may reference this trial for context on trial design, inclusion criteria (serum ferritin <35 µg/L), and outcome measures when developing similar protocols.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
N/A NCT07546591 Kind: NA Apr 23, 2026
Abstract
This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin <35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily.
Primary outcomes include changes in ferritin and hematological parameters. Secondary outcomes include VO₂peak, time to exhaustion, and blood lactate responses during standardized treadmill testing.
This study will determine whether lactoferrin enhances iron homeostasis and improves physiological and performance outcomes in exercising women with low iron stores.
Conditions: Iron Deficiencies, Low Ferritin, Iron Deficiency, Exercise Performance of Fit Athletes
Interventions: Lactoferrin 100 mg, Lactoferrin 300 mg, Iron Supplementation (5 mg)
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