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NOT YET RECRUITING
NCT07156526
NA

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

Sponsor: Qualia Life Sciences

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Qualia Life Sciences

Carlsbad, California, United States