Anemia, Iron-Deficiency, Cystic Fibrosis
Conditions
Keywords
Cystic fibrosis, Iron, Hepcidin, Anemia, Erythropoiesis
Brief summary
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.
Interventions
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
DRUGPlacebo
Matching placebo capsule
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* History of Pseudomonas aeruginosa colonization of the lung * Transferrin saturation (TSAT) less than or equal to 21% * Hemoglobin concentration \<15.5 gm/dl (men) * Hemoglobin concentration \<13.6 gm/dl (women)
Exclusion criteria
* Use of iron-containing vitamin or supplement * Pregnancy * Lactation * Cirrhosis * History of chronic visible (gross) hemoptysis * Hereditary hemochromatosis * History of transfusion-related iron overload * Use of iron chelator(s) * Withdrawal of informed consent * Contraindication to phlebotomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Hemoglobin Concentration (gm/dl) | Baseline and 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Serum Iron (mcg/dl) | Baseline and 6 weeks |
| Change From Baseline in Transferrin Saturation (%) | Baseline and 6 weeks |
| Change From Baseline in Sputum Iron (ng/mg) | Baseline and 6 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes those who started the study with First Intervention and those who started the study with Second Intervention | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 32.1 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 22 | 11 / 22 |
| serious Total, serious adverse events | 4 / 22 | 3 / 22 |
Outcome results
Primary
Change From Baseline in Hemoglobin Concentration (gm/dl)
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin Concentration (gm/dl) | 0.12 gm/dl | Standard Error 0.13 |
| Ferrous Sulfate | Change From Baseline in Hemoglobin Concentration (gm/dl) | 0.09 gm/dl | Standard Error 0.13 |
Comparison: Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).p-value: 0.81Fixed-effect model
Secondary
Change From Baseline in Serum Iron (mcg/dl)
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Serum Iron (mcg/dl) | 13.7 mcg/dl | Standard Error 5.9 |
| Ferrous Sulfate | Change From Baseline in Serum Iron (mcg/dl) | -4.2 mcg/dl | Standard Error 5.7 |
p-value: <0.05Fixed-effect model
Secondary
Change From Baseline in Sputum Iron (ng/mg)
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Sputum Iron (ng/mg) | 0.13 ng/mg | Standard Error 0.17 |
| Ferrous Sulfate | Change From Baseline in Sputum Iron (ng/mg) | 0.42 ng/mg | Standard Error 0.21 |
p-value: 0.16Fixed-effect model
Secondary
Change From Baseline in Transferrin Saturation (%)
Time frame: Baseline and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Transferrin Saturation (%) | 4.7 % saturation | Standard Error 1.5 |
| Ferrous Sulfate | Change From Baseline in Transferrin Saturation (%) | -1.8 % saturation | Standard Error 1.7 |
Comparison: Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).p-value: <0.05Fixed-effect model