Iron DeficienciesNCT07156526
Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
A study testing Qualia Iron Version A and Qualia Iron Version B in people with Iron Deficiencies, run by Qualia Life Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiencies
- What is being tested?
- Qualia Iron Version A and Qualia Iron Version B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Qualia Life Sciences
Carlsbad, California, 92011
Abhi Ardagh, 855-281-2328, support@qualialife.com
About this study
Official title: Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Double-Blind Pilot Study
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.
Read the detailed description
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.
- Conditions
- Iron Deficiencies
- Being tested
- Qualia Iron Version A, Qualia Iron Version B, Placebo
- Keywords
- Iron supplementation, Iron deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia Iron Version ADietary supplement
Qualia Iron Version A manufactured by Qualia Life Sciences
Qualia Iron Version BDietary supplement
Qualia Iron Version B manufactured by Qualia Life Sciences
PlaceboDietary supplement
Rice powder
| Study group | Role | What they receive |
|---|---|---|
| Qualia Iron Version A | Active comparator | Qualia Iron version A manufactured by Qualia Life Sciences Receives: Dietary Supplement: Qualia Iron Version A |
| Qualia Iron Version B | Active comparator | Qualia Iron version B manufactured by Qualia Life Sciences Receives: Dietary Supplement: Qualia Iron Version B |
| Placebo | Placebo comparator | Rice powder Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in iron status biomarkers
Between-groups changes in ferritin levels (ng/mL) will be assessed.
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Secondary outcomes (14)
Changes in iron status biomarkers
Changes in serum iron (mcg/dL)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Changes in percent saturation (%)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
Changes in total iron binding capacity (mcg/dL)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in hematocrit (%)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in hemoglobin (g/dL)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in red cell distribution width (%)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular volume (fL)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular hemoglobin (pg)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in mean corpuscular hemoglobin concentration (g/dL)
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
Changes in red blood cell count (million/microliter)
Measured: 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.
Measured: 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.
Measured: From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in inflammatory markers
Changes in high sensitivity C-reactive protein (mg/L)
Measured: 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.
Measured: From 0-4 weeks, 4-8 weeks and 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start18 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron DeficienciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Scuba, Principal investigator, Qualia Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156526
- Sponsor's protocol ID
- QLS-015
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Double-Blind Pilot Study
- ClinicalTrials.gov ID
- NCT07156526
- Acronym / sponsor ID
- QLS-015
- Conditions
- Iron Deficiencies
- Keywords
- Iron supplementation, Iron deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qualia Iron Version A | Active comparator | Dietary Supplement: Qualia Iron Version AQualia Iron version A manufactured by Qualia Life Sciences |
| Qualia Iron Version B | Active comparator | Dietary Supplement: Qualia Iron Version BQualia Iron version B manufactured by Qualia Life Sciences |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboRice powder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia Iron Version AQualia Iron Version A manufactured by Qualia Life Sciences | Dietary supplement | Qualia Iron Version A |
| Qualia Iron Version BQualia Iron Version B manufactured by Qualia Life Sciences | Dietary supplement | Qualia Iron Version B |
| PlaceboRice powder | Dietary supplement | Placebo |
Primary outcome
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.
14 secondary outcomes
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
Changes in inflammatory markers
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiencies
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Scuba principal investigator
Qualia Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Iron Version A and Qualia Iron Version B in people with Iron Deficiencies, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Scuba (855-281-2328, support@qualialife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in iron status biomarkers (time frame: From 0-4 weeks, 4-8 weeks, and 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.