Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Dartmouth-Hitchcock Medical Center22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis Anemia, Iron-Deficiency

Interventions

Ferrous sulfate 325mgDRUG

Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks

PlaceboDRUG

Matching placebo capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Maine Medical Center

Portland, Maine, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin Concentration (gm/dl)

Time frame: Baseline and 6 weeks

Secondary Outcomes

Change From Baseline in Serum Iron (mcg/dl)

Time frame: Baseline and 6 weeks

Change From Baseline in Transferrin Saturation (%)

Time frame: Baseline and 6 weeks

Change From Baseline in Sputum Iron (ng/mg)

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

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