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NCT Number: NCT07156526

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

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.

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Key information

Conditions

Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Changes in iron status biomarkers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Between-groups changes in ferritin levels (ng/mL) will be assessed.

Secondary outcomes

  1. Changes in iron status biomarkers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in serum iron (mcg/dL)

  2. Changes in iron status biomarkers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in percent saturation (%)

  3. Changes in iron status biomarkers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in total iron binding capacity (mcg/dL)

  4. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in hematocrit (%)

  5. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in hemoglobin (g/dL)

  6. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in red cell distribution width (%)

  7. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in mean corpuscular volume (fL)

  8. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in mean corpuscular hemoglobin (pg)

  9. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in mean corpuscular hemoglobin concentration (g/dL)

  10. Changes in CBC markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in red blood cell count (million/microliter)

  11. Changes in RAND 36-Item Short Form Survey (SF-36)

    Time frame: From 0-4 weeks, 4-8 weeks, 0-8 weeks

    The RAND SF-36 captures 8 separate aspects of health-related quality of life using the same 0-to-100 scoring scale for all eight domains. Higher scores represent better health outcomes.

  12. Changes in Safety and Tolerability measured by Custom Survey

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in safety and tolerability measures will be examined in each group using a custom survey. The survey asks about common nocibo side effects, including increasing anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual function. The scoring system goes from "not at all" to "a great deal" for each item, . The total score for each category across all participants will be calculated, and then timepoint comparisons will be made.

  13. Changes in inflammatory markers

    Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks

    Changes in high sensitivity C-reactive protein (mg/L)

  14. Changes in iron status biomarkers

    Time frame: From 0-4 weeks, 4-8 weeks and 0-8 weeks

    Within-groups changes in ferritin (ng/mL) will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

William Scuba

CONTACT

[email protected]

855-281-2328

Sponsors and collaborators

Lead sponsor

Qualia Life Sciences

Industry

Registry information

Official study title

Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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