NCT07156526

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

Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Qualia Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Iron Deficiencies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Qualia Iron Version A	Qualia Iron Version A manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENT	Qualia Iron Version B	Qualia Iron Version B manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENT	Placebo	Rice powder

Timeline

• Start date: 2025-09-10
• Primary completion: 2025-11-15
• Completion: 2025-11-15
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States