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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+