Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis Anemia, Iron-Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ferrous sulfate 325mg

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

Group Type ACTIVE_COMPARATOR

Ferrous sulfate 325mg

Intervention Type DRUG

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

Placebo

Identical-appearing tablet taken by mouth daily for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsule

Interventions

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Ferrous sulfate 325mg

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

Intervention Type DRUG

Placebo

Matching placebo capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No