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Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
Sponsor: Qualia Life Sciences
Summary
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.
Official title: Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-09-10
Completion Date
2025-11-15
Last Updated
2025-09-05
Healthy Volunteers
Yes
Conditions
Interventions
Qualia Iron Version A
Qualia Iron Version A manufactured by Qualia Life Sciences
Qualia Iron Version B
Qualia Iron Version B manufactured by Qualia Life Sciences
Placebo
Rice powder
Locations (1)
Qualia Life Sciences
Carlsbad, California, United States