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Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01755455
First Posted: December 24, 2012
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alex H. Gifford, Dartmouth-Hitchcock Medical Center
  Purpose
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.

Condition Intervention
Cystic Fibrosis Anemia, Iron-Deficiency Drug: Ferrous sulfate 325mg Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Alex H. Gifford, Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin Concentration (gm/dl) [ Time Frame: Baseline and 6 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755455


Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Alex H Gifford, M.D. Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Alex H. Gifford, Assistant Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01755455     History of Changes
Other Study ID Numbers: D11176
CPHS#22884 ( Other Grant/Funding Number: The Flatley Foundation )
First Submitted: December 19, 2012
First Posted: December 24, 2012
Results First Submitted: December 31, 2013
Results First Posted: October 6, 2014
Last Update Posted: March 16, 2017
Last Verified: February 2017

Keywords provided by Alex H. Gifford, Dartmouth-Hitchcock Medical Center:
Cystic fibrosis
Iron
Hepcidin
Anemia
Erythropoiesis

Additional relevant MeSH terms:
Anemia
Fibrosis
Cystic Fibrosis
Anemia, Iron-Deficiency
Hematologic Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases