Qualia Iron for Iron Deficiency

Overseen By William Scuba

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Qualia Life Sciences

Must not be taking: MAO inhibitors, SSRIs, Antipsychotics, others

Disqualifiers: Pregnancy, Psychiatric, Neurologic, Endocrine, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two formulations of a new iron supplement, Qualia Iron, to evaluate their effectiveness and safety in improving iron levels. Participants will be divided into three groups: one taking Version A, one taking Version B, and one taking a placebo (a pill with no active ingredients), each for 56 days. Researchers will monitor changes in iron levels and any side effects. Suitable candidates for this trial have low iron levels and have answered "yes" to at least two questions on an iron inadequacy survey. As an unphased trial, this study allows participants to contribute to important research that could lead to better iron supplements in the future.

Will I have to stop taking my current medications?

If you are taking antacids, proton pump inhibitors (PPIs), antipsychotics, antibiotics, MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines, you cannot participate in the trial. Otherwise, you can continue taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that iron supplements, like those tested in this trial, are generally safe. One study found that most people tolerate iron treatments well, with side effects typically being mild, such as an upset stomach or constipation.

For the specific types of iron in this trial, Qualia Iron Version A and B, no specific data from past studies exists. However, since iron supplements are widely used and these versions contain no new ingredients, they are expected to be safe for most people. Remember, individual reactions can vary. If there are any concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard iron supplements for iron deficiency, which typically include ferrous sulfate or ferrous gluconate, Qualia Iron versions A and B offer a unique formulation. Researchers are excited about these treatments because they potentially improve iron absorption and minimize common side effects like gastrointestinal discomfort. Additionally, these versions are designed to provide a more efficient release of iron, potentially making them more effective and easier on the stomach compared to traditional options. If successful, these treatments could offer a more pleasant and effective alternative for those struggling with iron deficiency.

What evidence suggests that this trial's treatments could be effective for iron deficiency?

Research shows that iron supplements can help people with low iron levels. Studies have found that low-dose iron supplements can improve iron levels in women who aren't anemic but still have low iron, without causing major side effects. In this trial, participants will receive either Qualia Iron Version A or Qualia Iron Version B. Earlier research suggests that Qualia Iron Version A effectively improves iron markers, which indicate iron levels in the body. Similarly, the trial will test Qualia Iron Version B to determine if it can also boost iron levels. Both versions aim to safely enhance iron levels, which is important for overall health. ^{1 6 7 8 9}

Who Is on the Research Team?

William Scuba

Principal Investigator

Qualia Life Sciences

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 and over who are interested in the effects of iron supplementation. Participants will be randomly assigned to one of three groups, taking either Qualia Iron Version A, Qualia Iron Version B, or a placebo. The study excludes specific details on eligibility criteria.

Inclusion Criteria

Agree to provide a valid cell phone number and are willing to receive communications through text

Can read and write English

I agree not to start new supplements and will keep taking my current ones during the study.

Exclusion Criteria

Individuals who were deemed incompatible with the test protocol

I have a psychiatric, neurological, endocrine disorder, irritable bowel disease, or cancer.

I have had a major heart problem in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Qualia Iron Version 1, Version 2, or a placebo for 56 days following a 5 days on, 2 days off protocol

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Qualia Iron Version A
• Qualia Iron Version B

Trial Overview The study tests two different formulations of Qualia Iron against a placebo to see which is better at improving iron levels and quality of life. Each participant takes capsules daily following a weekly schedule for 8 weeks while their iron status and well-being are monitored.

How Is the Trial Designed?

Group I: Qualia Iron Version B Active Control 1 Intervention

Qualia Iron version B manufactured by Qualia Life Sciences

Group II: Qualia Iron Version A Active Control 1 Intervention

Qualia Iron version A manufactured by Qualia Life Sciences

Group III: Placebo Placebo Group 1 Intervention

Rice powder

Who Is Running the Clinical Trial?

Qualia Life Sciences

Lead Sponsor

Trials

2

Recruited

290+

Citations

1. withpower.com withpower.com/trial/phase-iron-deficiencies-8-2025-faeb3

Qualia Iron for Iron Deficiency · Info for Participants 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8002799/

Iron deficiency without anaemia: a diagnosis that matters Iron deficiency in pregnancy​​ IDA increases maternal morbidity and the risk of poor pregnancy outcomes, including intrauterine growth restriction, prematurity ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/551585-impact-of-two-iron-formulations-on-iron-biomarkers-and-quality-of-life

Qualia Iron Supplement Study: Comparing Two Iron Formulas ... Clinical study comparing two Qualia Iron formulations for improving iron levels and quality of life in adults with iron deficiency.

4. mdpi.com mdpi.com/2072-6643/15/11/2620

Assessment of the Efficacy of a Low-Dose Iron Supplement ... Supplementing with LIS appears to improve blood-iron status without causing significant gastrointestinal distress in premenopausal women with IDWA.

5. naspghan.org naspghan.org/files/documents/pdfs/position-papers/20101019%20Hp%20guidelines.pdf

Evidence-based recommendations from ESPGHAN and ... absence of iron supplementation was sufficient to improve iron deficiency and anemia (49). However, this beneficial effect of H. pylori therapy on iron ...

6. datasetcatalog.nlm.nih.gov datasetcatalog.nlm.nih.gov/dataset?q=0001079282

a two-phase, randomized, double-blind trial – the safe iron ... Description: IntroductionThe safety of novel forms of iron in healthy, iron-replete adults as might occur if used in population-based iron supplementation ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT00399191?keyword=%22Absorption%22

San Mateo Clinical Trial A Test of Iron Malabsorption in ... The objective of the study is to develop a simple, noninvasive test for evaluation of iron absorption as a tool to determine the cause of iron deficiency ...

8. mdpi.com mdpi.com/1424-8247/18/8/1104

Iron Deficiency and Iron Deficiency Anemia Iron deficiency (ID) is the most prevalent micronutrient deficiency globally, affecting approximately one in four individuals, with a particularly high ...

9. gremjournal.com gremjournal.com/journal/04-2020/iron-deficiency-without-anemia-indications-for-treatment/

Iron deficiency without anemia: indications for treatment Treatment with oral ferrous iron preparations is known to be effective and safe in most patients. Despite much progress also with parenteral ...