Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
Safety and Efficacy of Two Qualia Iron Formulations on Iron Biomarkers and Quality of Life: A Randomized, Double-Blind Pilot Study
1 other identifier
interventional
40
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
September 5, 2025
CompletedStudy Start
First participant enrolled
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedSeptember 5, 2025
August 1, 2025
2 months
August 12, 2025
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in iron status biomarkers
Between-groups changes in ferritin levels (ng/mL) will be assessed.
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Secondary Outcomes (14)
Changes in iron status biomarkers
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in iron status biomarkers
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
Changes in CBC markers
From 0-4 weeks, 4-8 weeks, and 0-8 weeks
- +9 more secondary outcomes
Study Arms (3)
Qualia Iron Version A
ACTIVE COMPARATORQualia Iron version A manufactured by Qualia Life Sciences
Qualia Iron Version B
ACTIVE COMPARATORQualia Iron version B manufactured by Qualia Life Sciences
Placebo
PLACEBO COMPARATORRice powder
Interventions
Qualia Iron Version A manufactured by Qualia Life Sciences
Qualia Iron Version B manufactured by Qualia Life Sciences
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qualia Life Sciences
Carlsbad, California, 92011, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Scuba
Qualia Life Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
September 5, 2025
Study Start
September 10, 2025
Primary Completion
November 15, 2025
Study Completion
November 15, 2025
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share