Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis

Sponsors

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Source Dartmouth-Hitchcock Medical Center
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.

Overall Status Completed
Start Date June 2011
Completion Date November 2012
Primary Completion Date November 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Hemoglobin Concentration (gm/dl) Baseline and 6 weeks
Secondary Outcome
Measure Time Frame
Change From Baseline in Serum Iron (mcg/dl) Baseline and 6 weeks
Change From Baseline in Transferrin Saturation (%) Baseline and 6 weeks
Change From Baseline in Sputum Iron (ng/mg) Baseline and 6 weeks
Enrollment 22
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ferrous sulfate 325mg

Description: Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks

Arm Group Label: Ferrous sulfate 325mg

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo capsule

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Alex H Gifford, M.D. Principal Investigator Dartmouth-Hitchcock Medical Center
Location
Facility:
Maine Medical Center | Portland, Maine, 04102, United States
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
Location Countries

United States

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Dartmouth-Hitchcock Medical Center

Investigator Full Name: Alex H. Gifford

Investigator Title: Assistant Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ferrous sulfate 325mg

Type: Active Comparator

Description: Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks

Label: Placebo

Type: Placebo Comparator

Description: Identical-appearing tablet taken by mouth daily for 6 weeks

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov