University of Michigan
The researchers in this study hope to learn whether oral (PO) or intravenous (IV) iron treatments are better for treating iron deficiency in patients with cystic fibrosis (CF). This research will help doctors better treat iron deficiency in patients with CF in the future by examining blood and other health measures.
Participants with cystic fibrosis (CF) will be enrolled in this study. Approximately 80 participants will be enrolled in the Iron Deficient (ID) Cohort; and approximately 20 participants will be enrolled in the Borderline ID Cohort. Participants enrolled in the ID Cohort will be randomized to either an IV versus PO route of iron repletion. Participants enrolled in the Borderline ID Cohort will be randomized to a PO route of iron repletion versus usual care without specific assignment of iron repletion. The focus of the study is the ID Cohort; the Borderline ID Cohort is exploratory.
Inclusion Criteria for All Study Participants: 1. A CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and at least one of the following criteria: 1. sweat chloride ≥ 60 milliequivalent/liter by quantitative pilocarpine iontophoresis test (QPIT) 2. two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene 3. abnormal nasal potential difference (NPD, change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV) 2. Ability to provide written informed consent and to compl…
Possible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: low molecular weight iron dextran; ferric carboxymaltose; ferric derisomaltose.
Possible formulation and dose will depend on the participant's treating clinician, and may include but is not limited to the following: ferrous sulfate (325 mg/65 mg elemental iron every other day).