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Completed

NCT Number: NCT00450177

Efficacy of Enteral Iron Supplementation in Critical Illness

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 supplementation and risk of infection.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weill Medical College of Cornell University

New York, 10021, United States

About this study

Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial 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 purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Anemia (Hemoglobin < 13.0 g/dL)
  • ≤ 72 hours from hospital admission
  • Current tolerance of enteral medications
  • Expected ICU LOS > 5 days

Exclusion criteria

  • Active bleeding
  • Chronic inflammatory disease
  • End-stage renal disease
  • Hematologic disorders
  • Macrocytic anemia
  • Current use of erythropoietin
  • Pregnancy
  • Prohibition of RBC transfusions
  • Moribund state in which death is imminent
  • Enrollment in another clinical trial

Treatment and study plan

Ferrous Sulfate

Drug

Iron group

Placebo oral tablet

Drug

Placebo group

Primary outcomes

  1. Hematocrit

    Time frame: Day 7, Day 14, Day 21, Day 28

  2. Serum Iron Concentration

    Time frame: Day 7, Day 14, Day 21, Day 28

  3. Serum Ferritin Concentration

    Time frame: Day 7, Day 14, Day 21, Day 28

  4. Erythrocyte Zinc Protoporphyrin Concentration

    Time frame: Day 7, Day 14, Day 21, Day 28

Secondary outcomes

  1. Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital

    Time frame: Throughout hospital stay up to 6 weeks

  2. Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission

    Time frame: Throughout hospital stay up to 6 weeks

  3. Instance of Drug-related Constipation Throughout Hospital Admission

    Time frame: Throughout hospital stay up to 6 weeks

  4. Average Number of Days That Subjects Were Taking Antibiotics

    Time frame: Throughout hospital stay up to 6 weeks

  5. Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital

    Time frame: Throughout hospital stay up to 6 weeks

  6. Average Length of Stay in the Hospital

    Time frame: Throughout hospital stay up to 6 weeks

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Mar 21, 2007
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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