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Not yet recruiting NCT07156526

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

No phase Interventional Iron Deficiencies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qualia Iron Version A, Qualia Iron Version B, Placebo.
Who it may be relevant to
Registry conditions: Iron Deficiencies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Primary outcome measures

  • Changes in iron status biomarkers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
Secondary outcome measures (12)
  • Changes in iron status biomarkers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in iron status biomarkers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in iron status biomarkers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in CBC markers [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]
  • Changes in RAND 36-Item Short Form Survey (SF-36) [Time frame: From 0-4 weeks, 4-8 weeks, 0-8 weeks]
  • Changes in Safety and Tolerability measured by Custom Survey [Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Qualia Life Sciences — Carlsbad

Identifiers

NCT: NCT07156526 · QLS-015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗