Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life
ConditionIron Deficiencies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQualia Life Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Qualia Iron Version A
Dietary supplementQualia Iron Version A manufactured by Qualia Life Sciences
Qualia Iron Version B
Dietary supplementQualia Iron Version B manufactured by Qualia Life Sciences
Placebo
Dietary supplementRice powder
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Qualia Iron Version AActive comparator 1 intervention
Group B: Qualia Iron Version BActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in iron status biomarkers
Between-groups changes in ferritin levels (ng/mL) will be assessed.
Time frame
From 0-4 weeks, 4-8 weeks, and 0-8 weeksSecondary outcomes
1
Changes in iron status biomarkers
Changes in serum iron (mcg/dL)
Time frame
From 0-4 weeks, 4-8 weeks, and 0-8 weeks2
Changes in iron status biomarkers
Changes in percent saturation (%)
Time frame
From 0-4 weeks, 4-8 weeks, and 0-8 weeks3
Changes in iron status biomarkers
Changes in total iron binding capacity (mcg/dL)
Time frame
From 0-4 weeks, 4-8 weeks, and 0-8 weeks4
Changes in CBC markers
Changes in hematocrit (%)
Time frame
From 0-4 weeks, 4-8 weeks, and 0-8 weeksSponsors and contacts
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Source ClinicalTrials.gov