Status:
NOT_YET_RECRUITING
Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
Lead Sponsor:
Qualia Life Sciences
Conditions:
Iron Deficiencies
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 peri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07156526
Start Date
September 10 2025
End Date
November 15 2025
Last Update
September 5 2025
Active Locations (1)
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1
Qualia Life Sciences
Carlsbad, California, United States, 92011