Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life

This randomized, double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period. Approximately 40 participants will be randomized to three study arms: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10). Each participant will take one or two capsules once daily in the morning, with or without food. The supplementation regimen is a 5 days on, 2 days off protocol, and goes for 56 days (8 weeks). The primary outcomes of this study are to assess between-group changes in iron status biomarkers. Secondary outcomes include within-group changes in iron status biomarkers, safety and tolerability as measured by a custom Safety and Tolerability survey, and RAND SF-36 quality of life scores.

NCT Number	NCT07156526
Lead Sponsor	Qualia Life Sciences
Conditions	Iron Deficiencies
Enrollment	40 participants
Start Date	2025-09-10
Primary Completion	2025-11-15 (estimated)
Study Completion	2025-11-15 (estimated)
Updated on ClinicalTrials.gov	2025-09-05