Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alex H. Gifford, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01755455
First received: December 19, 2012
Last updated: December 21, 2012
Last verified: December 2012
  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:
  • Hemoglobin concentration (gm/dl) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum iron (mcg/dl) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Transferrin saturation (%) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Serum hepcidin-25 (ng/ml) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Serum erythropoietin (mU/ml) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Percent-predicted forced expiratory volume in one second (FEV1%) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Body weight (kg) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Akron Pulmonary Exacerbation Score (PES) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Sputum iron (ng/mg) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: June 2011
Estimated Primary Completion Date: January 2013 (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

  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

No publications provided

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
Last Updated: December 21, 2012
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
Cystic Fibrosis
Fibrosis
Anemia, Iron-Deficiency
Hematologic Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014