[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604977":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":61,"collaborators":30,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":30,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":30,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Qualia Life Sciences","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Qualia Iron Version A","ACTIVE_COMPARATOR","Qualia Iron version A manufactured by Qualia Life Sciences",[13],"Dietary Supplement: Qualia Iron Version A",{"label":15,"type":10,"description":16,"interventionNames":17},"Qualia Iron Version B","Qualia Iron version B manufactured by Qualia Life Sciences",[18],"Dietary Supplement: Qualia Iron Version B",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Rice powder",[24],"Dietary Supplement: Placebo",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Qualia Iron Version A manufactured by Qualia Life Sciences",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Qualia Iron Version B manufactured by Qualia Life Sciences",[15],{"type":27,"name":20,"description":22,"armGroupLabels":35,"otherNames":30},[20],[37],{"name":38,"affiliation":5,"role":39},"William Scuba","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":30,"email":44},"CONTACT","855-281-2328","support@qualialife.com",[46],{"facility":5,"status":30,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Carlsbad","California","92011","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.35059,33.15809,{"lat":56,"lon":55},[59],{"name":60,"role":42,"phone":43,"phoneExt":30,"email":44},"Abhi Ardagh",{"type":62,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100604977","impact-of-two-iron-formulations-on-iron-biomarkers-and-quality-of-life-100604977",false,"NCT07156526","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","Inclusion Criteria:\n\n* Provide voluntary, written, informed consent to participate in the study\n* Agree to provide a valid cell phone number and are willing to receive communications through text\n* Can read and write English\n* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly\n* Willing to complete questionnaires, records, and diaries associated with the study.\n* If the participant responded \"Yes\" to ≥2 questions on the custom Iron Inadequacy Questionnaire. Preference will be given to participants with a higher score.\n* If a participant has the following:\n\nFerritin 30 ng\u002FmL (anything under 50 ng\u002FmL is considered suboptimal, but participants with 30 ng\u002FmL will be prioritized)\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial\n* Known food intolerances\u002Fallergy to any ingredients in the product\n* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, irritable bowel disease, cancer\n* Having had a significant cardiovascular event in the past 6 months\n* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines\n* On immunosuppressive therapy\n* Individuals who were deemed incompatible with the test protocol\n* Adults lacking capacity to consent\n* Individuals taking any of the following medications:\n\nAntacids Proton pump inhibitors (PPIs) Antipsychotics Antibiotics",true,"ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81],"Iron Deficiencies",[83,84],"Iron supplementation","Iron deficiency","NOT_YET_RECRUITING","2025-08-27",{"date":88,"type":89},"2025-09-05","ACTUAL",{"date":91,"type":75},"2025-09-10",{"date":93,"type":75},"2025-11-15",{"name":5,"class":6},1]