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CompletedNCT00450177Updated Jul 18, 2019Results posted

Efficacy of Enteral Iron Supplementation in Critical Illness

A Phase 2 interventional study of Ferrous Sulfate and Placebo Oral Tablet in Anemic, Critically Ill Patients, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-18.

Sponsored by Weill Medical College of Cornell University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2006, registered Mar 2007).
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 supplementation and risk of infection.

Read the detailed description

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.

02

Conditions studied

  • Anemic, Critically Ill Patients

Keywords

  • iron
  • critical illness
  • anemia
  • infection
03

In context

Critical Illness

1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.

This study's enrollment of 200 is above the median of 90 across 1,003 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 164 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Iron Group

    Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

    Drug: Ferrous Sulfate

  • Placebo comparator
    Placebo Group

    Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

    Drug: Placebo Oral Tablet

Interventions

06

What researchers measure

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

07

Results

Posted Jul 8, 2019

Participant flow

Participant flow — Overall Study
MilestoneIron GroupPlacebo Group
Started97103
Completed8892
Not completed911
Withdrew: Adverse event74
Withdrew: Withdrawal by subject16
Withdrew: Withdrawal by primary team11

Outcome measures

PrimaryHematocrit
Time frame:
Day 7, Day 14, Day 21, Day 28
Reported as:
Mean · percentage of RBC in blood
Hematocrit
percentage of RBC in bloodIron GroupPlacebo Group
Day 729.3 ± 0.529.1 ± 0.5
Day 1428.6 ± 0.428.2 ± 0.5
Day 2129.2 ± 0.428.1 ± 0.6
Day 2827.8 ± 0.628.1 ± 0.5
PrimarySerum Iron Concentration
Time frame:
Day 7, Day 14, Day 21, Day 28
Reported as:
Mean · mcg/mL
Serum Iron Concentration
mcg/mLIron GroupPlacebo Group
Day 735 ± 0.637 ± 0.7
Day 1434 ± 0.534 ± 0.7
Day 2134 ± 0.640 ± 0.6
Day 2837 ± 0.536 ± 0.7
PrimarySerum Ferritin Concentration
Time frame:
Day 7, Day 14, Day 21, Day 28
Reported as:
Mean · ng/mL
Serum Ferritin Concentration
ng/mLIron GroupPlacebo Group
Day 7280 ± 46265 ± 73
Day 14268 ± 51268 ± 80
Day 21251 ± 40355 ± 83
Day 28383 ± 54361 ± 76
PrimaryErythrocyte Zinc Protoporphyrin Concentration
Time frame:
Day 7, Day 14, Day 21, Day 28
Reported as:
Mean · micromol:mol heme
Erythrocyte Zinc Protoporphyrin Concentration
micromol:mol hemeIron GroupPlacebo Group
Day 769 ± 467 ± 5
Day 1475 ± 677 ± 5
Day 2186 ± 591 ± 6
Day 2884 ± 689 ± 5
SecondaryNumber of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Count of participants · Participants
Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
ParticipantsIron GroupPlacebo Group
Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital2946
Statistical analysis
  • Iron Group vs Placebo Group · Chi-squared · p = 0.03
SecondaryNumber of Subjects That Incurred at Least One Infection Throughout Hospital Admission
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Count of participants · Participants
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
ParticipantsIron GroupPlacebo Group
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission4548
SecondaryInstance of Drug-related Constipation Throughout Hospital Admission
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Count of participants · Participants
Instance of Drug-related Constipation Throughout Hospital Admission
ParticipantsIron GroupPlacebo Group
Instance of Drug-related Constipation Throughout Hospital Admission129
SecondaryAverage Number of Days That Subjects Were Taking Antibiotics
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Mean · days
Average Number of Days That Subjects Were Taking Antibiotics
daysIron GroupPlacebo Group
Average Number of Days That Subjects Were Taking Antibiotics14 ± 216 ± 3
SecondaryHospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Count of participants · Participants
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
ParticipantsIron GroupPlacebo Group
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital910
SecondaryAverage Length of Stay in the Hospital
Time frame:
Throughout hospital stay up to 6 weeks
Reported as:
Mean · days
Average Length of Stay in the Hospital
daysIron GroupPlacebo Group
Average Length of Stay in the Hospital14 ± 116 ± 2

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Iron Group—0/97 (0%)7/97 (7.2%)
Placebo Group—0/103 (0%)4/103 (3.9%)
Most frequent other events
Most frequent other events
EventIron GroupPlacebo Group
Gastrointestinal upsetGastrointestinal disorders7/974/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)Iron GroupPlacebo GroupTotal
Mean55.7 ± 1.958.2 ± 1.757.0 ± 1.7
Sex: Female, Male
Sex: Female, Male(Participants)Iron GroupPlacebo GroupTotal
Female4855103
Male494897
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Iron GroupPlacebo GroupTotal
Count of participants——0
Baseline hematocrit
Baseline hematocrit(% of RBC in total blood volume)Iron GroupPlacebo GroupTotal
Mean32.0 ± 0.531.9 ± 0.431.9 ± 0.4
Baseline MCV
Baseline MCV(femtoliters)Iron GroupPlacebo GroupTotal
Mean88.7 ± 0.788.6 ± 0.888.6 ± 0.8
Baseline EBL
Baseline EBL(milliliters)Iron GroupPlacebo GroupTotal
Mean171 ± 45207 ± 50189 ± 48
Baseline RBC transfusion
Baseline RBC transfusion(Participants)Iron GroupPlacebo GroupTotal
Count of participants91928
Baseline RBC transfusion
Baseline RBC transfusion(milliliters)Iron GroupPlacebo GroupTotal
Mean135 ± 58303 ± 110222 ± 85

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Weill Medical College of Cornell University
    New York, New York 10021, United States
09

References and documents

Publications

  • Pieracci FM, Henderson P, Rodney JR, Holena DN, Genisca A, Ip I, Benkert S, Hydo LJ, Eachempati SR, Shou J, Barie PS. Randomized, double-blind, placebo-controlled trial of effects of enteral iron supplementation on anemia and risk of infection during surgical critical illness. Surg Infect (Larchmt). 2009 Feb;10(1):9-19. doi: 10.1089/sur.2008.043. PubMed 19245362 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2006 to primary completion in Dec 2007, 23 months.

Results were first posted in Jul 2019, 11 years 7 months after primary completion.

Of 35 non-industry phase 2 interventional studies under Critical Illness, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 23 months is below that.

Counting every sponsor, half of 36 studies reached it within 26 months; a quarter within 16 and three quarters within 44.

Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2007
First posted
Mar 21, 2007
StartActual
Jan 2006
Primary completionActual
Dec 2007
CompletionActual
Jan 2008
Results first posted
Jul 8, 2019
Last update
Jul 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00450177
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Mar 21, 2007
Start date
Jan 2006
Primary completion
Dec 2007
Completion
Jan 2008
Results posted
Jul 8, 2019
Last update
Jul 18, 2019

Study contacts

Philip S Barie, MD, MBA
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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