Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT01755455

Recruitment Status : Completed

First Posted : December 24, 2012

Results First Posted : October 6, 2014

Last Update Posted : March 16, 2017

Sponsor:

Information provided by (Responsible Party):

Alex H. Gifford, Dartmouth-Hitchcock Medical Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cystic Fibrosis Anemia, Iron-Deficiency	Drug: Ferrous sulfate 325mg Drug: Placebo	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	22 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis
Study Start Date :	June 2011
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	November 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Cystic fibrosis

MedlinePlus related topics: Anemia Cystic Fibrosis Iron

Drug Information available for: Ferrous sulfate Ferrous sulfate heptahydrate

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
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

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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

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

More Information

Additional Information:

Pubmed Entry This link exits the ClinicalTrials.gov site

Publications of Results:

Gifford AH, Alexandru DM, Li Z, Dorman DB, Moulton LA, Price KE, Hampton TH, Sogin ML, Zuckerman JB, Parker HW, Stanton BA, O'Toole GA. Iron supplementation does not worsen respiratory health or alter the sputum microbiome in cystic fibrosis. J Cyst Fibros. 2014 May;13(3):311-8. doi: 10.1016/j.jcf.2013.11.004. Epub 2013 Dec 13.

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Responsible Party:	Alex H. Gifford, Assistant Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT01755455
Other Study ID Numbers:	D11176 CPHS#22884 ( Other Grant/Funding Number: The Flatley Foundation )
First Posted:	December 24, 2012 Key Record Dates
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:

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

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