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Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alex H. Gifford, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01755455
First received: December 19, 2012
Last updated: October 3, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin Concentration (gm/dl) at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Serum Iron (mcg/dl) at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Transferrin Saturation (%) at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Sputum Iron (ng/mg) at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 19, 2012
Results First Received: December 31, 2013
Last Updated: October 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Cystic fibrosis
Iron
Hepcidin
Anemia
Erythropoiesis

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

ClinicalTrials.gov processed this record on November 25, 2014