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Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis, Anemia, Iron-Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferrous sulfate 325mg
Placebo
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Iron, Hepcidin, Anemia, Erythropoiesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maine Medical Center
  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ferrous sulfate 325mg

Placebo

Arm Description

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

Identical-appearing tablet taken by mouth daily for 6 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin Concentration (gm/dl)

Secondary Outcome Measures

Change From Baseline in Serum Iron (mcg/dl)
Change From Baseline in Transferrin Saturation (%)
Change From Baseline in Sputum Iron (ng/mg)

Full Information

First Posted
December 19, 2012
Last Updated
February 7, 2017
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01755455
Brief Title
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis
Official Title
Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Anemia, Iron-Deficiency
Keywords
Cystic fibrosis, Iron, Hepcidin, Anemia, Erythropoiesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferrous sulfate 325mg
Arm Type
Active Comparator
Arm Description
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical-appearing tablet taken by mouth daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Ferrous sulfate 325mg
Intervention Description
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsule
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin Concentration (gm/dl)
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Iron (mcg/dl)
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Transferrin Saturation (%)
Time Frame
Baseline and 6 weeks
Title
Change From Baseline in Sputum Iron (ng/mg)
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex H Gifford, M.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24332997
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24332997
Description
Pubmed Entry

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Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

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