Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Anemia, Iron-Deficiency
• Interventions: Drug: Ferrous sulfate 325mg; Drug: Placebo

• Registration Number: NCT01755455
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-24
• Results First Submitted: 2013-12-31
• Results First Submitted QC: 2014-10-03
• Results First Posted: 2014-10-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ferrous sulfate 325mg	Ferrous sulfate 325mg	Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
Placebo	Placebo	Identical-appearing tablet taken by mouth daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin Concentration (gm/dl)	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Maine Medical Center; 🇺🇸 Portland, Maine, United States