Efficacy of Enteral Iron Supplementation in Critical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00450177
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : April 3, 2008
Information provided by:
Weill Medical College of Cornell University

Brief Summary:
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplamentation and risk of infection.

Condition or disease Intervention/treatment Phase
Anemic, Critically Ill Patients Drug: Ferrous Sulfate 325 mg PO TID, or placebo Phase 2

Detailed Description:
Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoeisis into storage within the reticulendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purose of this study is to evaluate the efficacy of enteral iron supplamentation in critically ill patients. The hypothesis is that enteral iron supplamentation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness
Study Start Date : January 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Primary Outcome Measures :
  1. Weekly hemoglobin, days 0 -42
  2. Weekly serum iron concentration, days 0 - 42
  3. Weekly serum ferritin concentration, days 0 -42
  4. Weekly erythrocyte zinc protoporphyrin concentration, days 0 -42
  5. Blood transfusion
  6. Infection
  7. Drug-related Constipation
  8. Drug-related nausea/vomiting
  9. ICU mortality
  10. Hospital mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Anemia (Hemoglobin > 13.0 g/dL)
  • expected ICU LOS > 4 days

Exclusion Criteria:

  • active bleeding
  • chronic inflammatory disease
  • immunosuppression
  • hematogolic disease (e.g. thalassemia)
  • prohibited from receiving bloo transfusion
  • moribund state in which death is imminent

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 identifier (NCT number): NCT00450177

United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Philip S Barie, MD, MBA Weill Medical College of Cornell University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00450177     History of Changes
Other Study ID Numbers: 052007738
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: March 2008

Keywords provided by Weill Medical College of Cornell University:
critical illness

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes