Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT04320966
Eligibility Criteria:
Inclusion criteria (observational component):
* Age between 16 and 60 years of age.
* Any ethnicity.
* Either sex.
* Anemic group: hemoglobin less than 10.5 g/dl on screening hemoglobin.
* Control group: hemoglobin \>13.2 g/dl for females, \>14.6 g/dl for males, comparable age, sex and ethnicity to currently enrolled anemic subjects.
Exclusion criteria (observational component):
* Diabetes requiring medication.
* Hypertension requiring medication.
* Sleep disordered breathing requiring intervention.
* Body mass index \>35 (morbid obesity)
* Contraindications to MRI, including pacemaker, severe claustrophobia, pregnancy.
* Known systemic inflammatory disease such as inflammatory bowel disease, systemic lupus erythematosus, or scleroderma.
* Known HIV.
Inclusion criteria (interventional component):
* Criteria for observational component, plus
* ron deficiency anemia based upon attending hematologist interpretation of transferrin saturation, ferritin, and other ancillary labs including hs-CRP, MMA.
Exclusion criteria (interventional component):
* Criteria for observational component, plus
* Prior reaction to intravenous iron.
* History of multiple drug allergies.
* History of severe asthma, eczema, or atopy.
* Systemic mastocytosis.
* Severe respiratory or cardiac disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT04320966
Study Brief:
Protocol Section:
NCT04320966