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

NCT ID: NCT07156526

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2025-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Qualia Iron Version A

Qualia Iron version A manufactured by Qualia Life Sciences

Group Type ACTIVE_COMPARATOR

Qualia Iron Version A

Intervention Type DIETARY_SUPPLEMENT

Qualia Iron Version A manufactured by Qualia Life Sciences

Qualia Iron Version B

Qualia Iron version B manufactured by Qualia Life Sciences

Group Type ACTIVE_COMPARATOR

Qualia Iron Version B

Intervention Type DIETARY_SUPPLEMENT

Qualia Iron Version B manufactured by Qualia Life Sciences

Placebo

Rice powder

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Rice powder

Interventions

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Qualia Iron Version A

Qualia Iron Version A manufactured by Qualia Life Sciences

Intervention Type DIETARY_SUPPLEMENT

Qualia Iron Version B

Qualia Iron Version B manufactured by Qualia Life Sciences

Intervention Type DIETARY_SUPPLEMENT

Placebo

Rice powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Provide voluntary, written, informed consent to participate in the study
* Agree to provide a valid cell phone number and are willing to receive communications through text
* Can read and write English
* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
* Willing to complete questionnaires, records, and diaries associated with the study.
* If the participant responded "Yes" to ≥2 questions on the custom Iron Inadequacy Questionnaire. Preference will be given to participants with a higher score.
* If a participant has the following:

Ferritin 30 ng/mL (anything under 50 ng/mL is considered suboptimal, but participants with 30 ng/mL will be prioritized)

Exclusion Criteria

* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
* Known food intolerances/allergy to any ingredients in the product
* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, irritable bowel disease, cancer
* Having had a significant cardiovascular event in the past 6 months
* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
* On immunosuppressive therapy
* Individuals who were deemed incompatible with the test protocol
* Adults lacking capacity to consent
* Individuals taking any of the following medications:

Antacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qualia Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Scuba

Role: PRINCIPAL_INVESTIGATOR

Qualia Life Sciences

Locations

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Qualia Life Sciences

Carlsbad, California, United States

Site Status

Countries

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United States

Central Contacts

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William Scuba

Role: CONTACT

855-281-2328

Facility Contacts

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Abhi Ardagh

Role: primary

855-281-2328

Other Identifiers

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QLS-015

Identifier Type: -

Identifier Source: org_study_id

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