N/A
N=22
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
Cystic Fibrosis · Anemia, Iron-Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT01755455 ↗Enrolled (actual)
22
Serious AEs
15.9%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline in Hemoglobin Concentration (gm/dl) — 0.12; 0.09 gm/dl — p=0.81
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ferrous sulfate 325mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin Concentration (gm/dl) |
0.12; 0.09 | 0.81 |
| SECONDARY Change From Baseline in Serum Iron (mcg/dl) |
13.7; -4.2 | <0.05 sig |
| SECONDARY Change From Baseline in Transferrin Saturation (%) |
4.7; -1.8 | <0.05 sig |
| SECONDARY Change From Baseline in Sputum Iron (ng/mg) |
0.13; 0.42 | 0.16 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01755455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.