An interventional study of Qualia Iron Version A and Qualia Iron Version B in Iron Deficiencies, sponsored by Qualia Life Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Qualia Life Sciences · Not applicable, Interventional, and Other
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.
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.
This study's planned enrollment of 40 is below the median of 99 across 301 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →Qualia Life Sciences is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ferritin 30 ng/mL (anything under 50 ng/mL is considered suboptimal, but participants with 30 ng/mL will be prioritized)
Exclusion Criteria:
Antacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Qualia Iron version A manufactured by Qualia Life Sciences
Dietary Supplement: Qualia Iron Version A
Qualia Iron version B manufactured by Qualia Life Sciences
Dietary Supplement: Qualia Iron Version B
Rice powder
Dietary Supplement: Placebo
Qualia Iron Version A manufactured by Qualia Life Sciences
Qualia Iron Version B manufactured by Qualia Life Sciences
Rice powder
Changes in iron status biomarkers
Between-groups changes in ferritin levels (ng/mL) will be assessed.
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Changes in serum iron (mcg/dL)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Changes in percent saturation (%)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Changes in total iron binding capacity (mcg/dL)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in hematocrit (%)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in hemoglobin (g/dL)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in red cell distribution width (%)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular volume (fL)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular hemoglobin (pg)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular hemoglobin concentration (g/dL)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in red blood cell count (million/microliter)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in RAND 36-Item Short Form Survey (SF-36)
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.
Time frame: From 0-4 weeks, 4-8 weeks, 0-8 weeks
Changes in Safety and Tolerability measured by Custom Survey
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.
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in inflammatory markers
Changes in high sensitivity C-reactive protein (mg/L)
Time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Within-groups changes in ferritin (ng/mL) will be assessed.
Time frame: From 0-4 weeks, 4-8 weeks and 0-8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 88 interventional studies with no phase under Iron Deficiencies, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 6 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Sep 2025 → Jun 2026, primary completion Nov 2025 → Dec 2026 and completion Nov 2025 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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