Iron Deficiencies
Conditions
Keywords
Iron supplementation, Iron deficiency
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.
Interventions
DIETARY_SUPPLEMENTQualia Iron Version A
Qualia Iron Version A manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENTQualia Iron Version B
Qualia Iron Version B manufactured by Qualia Life Sciences
DIETARY_SUPPLEMENTPlacebo
Rice powder
Sponsors
Qualia Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in iron status biomarkers | From 0-4 weeks, 4-8 weeks, and 0-8 weeks | Between-groups changes in ferritin levels (ng/mL) will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in iron status biomarkers | From 0-4 weeks, 4-8 weeks, and 0-8 weeks | Changes in serum iron (mcg/dL) |
| Changes in CBC markers | From 0-4 weeks, 4-8 weeks, and 0-8 weeks | Changes in hematocrit (%) |
| Changes in RAND 36-Item Short Form Survey (SF-36) | From 0-4 weeks, 4-8 weeks, 0-8 weeks | The RAND SF-36 captures 8 separate aspects of health-related quality of life using the same 0-to-100 scoring scale for all eight domains. Higher scores represent better health outcomes. |
| Changes in Safety and Tolerability measured by Custom Survey | From 0-4 weeks, 4-8 weeks, and 0-8 weeks | Changes in safety and tolerability measures will be examined in each group using a custom survey. The survey asks about common nocibo side effects, including increasing anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual function. The scoring system goes from not at all to a great deal for each item, . The total score for each category across all participants will be calculated, and then timepoint comparisons will be made. |
| Changes in inflammatory markers | From 0-4 weeks, 4-8 weeks, and 0-8 weeks | Changes in high sensitivity C-reactive protein (mg/L) |
Countries
United States
Contacts
Primary ContactWilliam Scuba
Outcome results
None listed