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

Part of paid clinical trials in Carlsbad, California.

Sponsor
Qualia Life Sciences
Study ID
NCT07156526
Status
Not Yet Recruiting

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Conditions

  • Iron Deficiencies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Qualia Iron Version A — DIETARY_SUPPLEMENT
    Qualia Iron Version A manufactured by Qualia Life Sciences
  • Qualia Iron Version B — DIETARY_SUPPLEMENT
    Qualia Iron Version B manufactured by Qualia Life Sciences
  • Placebo — DIETARY_SUPPLEMENT
    Rice powder

Study Details

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.

Key Dates

Start date
Sep 10, 2025
Status verified
Aug 2025
Primary completion
Nov 15, 2025
Completion
Nov 15, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Qualia Iron Version A
    Qualia Iron version A manufactured by Qualia Life Sciences
  • Active Comparator: Qualia Iron Version B
    Qualia Iron version B manufactured by Qualia Life Sciences
  • Placebo Comparator: Placebo
    Rice powder

Primary Outcome Measure

Changes in iron status biomarkers [ Time Frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Qualia Life SciencesCarlsbadCalifornia92011
Abhi Ardagh
[email protected]
855-281-2328

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Qualia Life Sciences· Carlsbad, CA

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