Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

February 7, 2017 updated by: Alex H. Gifford, Dartmouth-Hitchcock Medical Center

Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ferrous sulfate 325mg
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
Drug: Ferrous sulfate 325mg
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
Placebo Comparator: Placebo
Identical-appearing tablet taken by mouth daily for 6 weeks
Drug: Placebo
Matching placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Hemoglobin Concentration (gm/dl)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Serum Iron (mcg/dl)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Change From Baseline in Transferrin Saturation (%)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks
Change From Baseline in Sputum Iron (ng/mg)
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Alex H Gifford, M.D., Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D11176
  • CPHS#22884 (Other Grant/Funding Number: The Flatley Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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