Iron Repletion for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Shijing Jia, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for people with cystic fibrosis who also have low iron levels or anemia. Participants should not have other major health issues that would prevent them from safely receiving iron treatments.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- IV Iron Repletion
- PO Iron Repletion
Trial Overview
The study compares two ways of giving iron to people with cystic fibrosis: by mouth (oral/PO) and through a vein (IV). Researchers want to see which method works better at improving iron levels and overall health.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration.
Participants enrolled in the ID Cohort will be randomized to an IV versus PO route of iron repletion in a 1:1 ratio. Participants are only randomized by route of repletion, not to a specified drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the IV route of administration.
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 in a 1:1 ratio. Participants are not randomized to a specific drug or dose. Rather, selection of the iron repletion formulation and dose will be determined by the participant's treating clinician. This arm is randomized to the PO route of administration.
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 in a 1:1 ratio. Usual care is defined as continued clinical care as usual without a specific plan to replete iron. This arm is randomized to usual care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.