Recruiting

Qualia Iron

Sponsor:

Qualia Life Sciences

Code:

NCT07156526

Conditions

Iron Deficiencies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Qualia Iron Version A

Qualia Iron Version B

Placebo

Study Details

Brief summary:

This 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 assigned 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

Study ID

NCT07156526

Start date

Jun 18, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Qualia Iron Version A

Qualia Iron Version A manufactured by Qualia Life Sciences

Qualia Iron Version B

Qualia Iron Version B manufactured by Qualia Life Sciences

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 and Locations

Central contacts

William Scuba

855-281-2328support@qualialife.com

Locations

Qualia Life Sciences

Recruiting

Carlsbad, California, United States, 92011

Contacts

Abhi Ardagh

855-281-2328support@qualialife.com

More Information

Sponsor

Qualia Life Sciences

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

  • Iron supplementation
  • Iron deficiency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Qualia Life Sciences on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.