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Efficacy of Enteral Iron Supplementation in Critical Illness

This study has been completed.
Information provided by:
Weill Medical College of Cornell University Identifier:
First received: March 20, 2007
Last updated: March 31, 2008
Last verified: March 2008
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 Intervention Phase
Anemic, Critically Ill Patients Drug: Ferrous Sulfate 325 mg PO TID, or placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Weekly hemoglobin, days 0 -42
  • Weekly serum iron concentration, days 0 - 42
  • Weekly serum ferritin concentration, days 0 -42
  • Weekly erythrocyte zinc protoporphyrin concentration, days 0 -42
  • Blood transfusion
  • Infection
  • Drug-related Constipation
  • Drug-related nausea/vomiting
  • ICU mortality
  • Hospital mortality

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00450177     History of Changes
Other Study ID Numbers: 052007738
Study First Received: March 20, 2007
Last Updated: March 31, 2008

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on August 18, 2017