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

NCT07156526 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qualia Life Sciences

    lead INDUSTRY

Principal Investigators

  • William Scuba · Qualia Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2025-11-15
Completion
2025-11-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156526 on ClinicalTrials.gov