Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755455
• Other study ID #: D11176
• Secondary ID: CPHS#22884
• Status: Completed
• Phase: N/A
• First received: December 19, 2012
• Last updated: October 3, 2014
• Start date: June 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2014
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Ferrous sulfate 325mg
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
• Placebo
Matching placebo capsule

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Fibro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin Concentration (gm/dl) at 6 Weeks		Baseline and 6 weeks	No
Secondary	Change From Baseline in Serum Iron (mcg/dl) at 6 Weeks		Baseline and 6 weeks	No
Secondary	Change From Baseline in Transferrin Saturation (%) at 6 Weeks		Baseline and 6 weeks	No
Secondary	Change From Baseline in Sputum Iron (ng/mg) at 6 Weeks		Baseline and 6 weeks	No

External Links

•   Pubmed Entry