Trial Outcomes & Findings for Efficacy of Enteral Iron Supplementation in Critical Illness (NCT NCT00450177)
NCT ID: NCT00450177
Last Updated: 2019-07-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Day 7, Day 14, Day 21, Day 28
Results posted on
2019-07-18
Participant Flow
Participant milestones
| Measure |
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.
Ferrous Sulfate: Iron group
|
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.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
103
|
|
Overall Study
COMPLETED
|
88
|
92
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
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.
Ferrous Sulfate: Iron group
|
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.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
|
Overall Study
Withdrawal by Primary Team
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 1.9 • n=97 Participants
|
58.2 years
STANDARD_DEVIATION 1.7 • n=103 Participants
|
57.0 years
STANDARD_DEVIATION 1.7 • n=200 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=97 Participants
|
55 Participants
n=103 Participants
|
103 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=97 Participants
|
48 Participants
n=103 Participants
|
97 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline hematocrit
|
32.0 % of RBC in total blood volume
STANDARD_DEVIATION 0.5 • n=97 Participants
|
31.9 % of RBC in total blood volume
STANDARD_DEVIATION 0.4 • n=103 Participants
|
31.9 % of RBC in total blood volume
STANDARD_DEVIATION 0.4 • n=200 Participants
|
|
Baseline MCV
|
88.7 femtoliters
STANDARD_DEVIATION 0.7 • n=97 Participants
|
88.6 femtoliters
STANDARD_DEVIATION 0.8 • n=103 Participants
|
88.6 femtoliters
STANDARD_DEVIATION 0.8 • n=200 Participants
|
|
Baseline EBL
|
171 milliliters
STANDARD_DEVIATION 45 • n=97 Participants
|
207 milliliters
STANDARD_DEVIATION 50 • n=103 Participants
|
189 milliliters
STANDARD_DEVIATION 48 • n=200 Participants
|
|
Baseline RBC transfusion
|
135 milliliters
STANDARD_DEVIATION 58 • n=97 Participants
|
303 milliliters
STANDARD_DEVIATION 110 • n=103 Participants
|
222 milliliters
STANDARD_DEVIATION 85 • n=200 Participants
|
|
Admission to enrollment
|
1.6 days
STANDARD_DEVIATION 0.1 • n=97 Participants
|
1.7 days
STANDARD_DEVIATION 0.1 • n=103 Participants
|
1.7 days
STANDARD_DEVIATION 0.1 • n=200 Participants
|
|
Admission APACHE II
|
15.9 units on a scale
STANDARD_DEVIATION 0.8 • n=97 Participants
|
14.9 units on a scale
STANDARD_DEVIATION 0.8 • n=103 Participants
|
15.4 units on a scale
STANDARD_DEVIATION 0.8 • n=200 Participants
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28Outcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Hematocrit
Day 7
|
29.3 percentage of RBC in blood
Standard Deviation 0.5
|
29.1 percentage of RBC in blood
Standard Deviation 0.5
|
|
Hematocrit
Day 14
|
28.6 percentage of RBC in blood
Standard Deviation 0.4
|
28.2 percentage of RBC in blood
Standard Deviation 0.5
|
|
Hematocrit
Day 21
|
29.2 percentage of RBC in blood
Standard Deviation 0.4
|
28.1 percentage of RBC in blood
Standard Deviation 0.6
|
|
Hematocrit
Day 28
|
27.8 percentage of RBC in blood
Standard Deviation 0.6
|
28.1 percentage of RBC in blood
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28Outcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Serum Iron Concentration
Day 7
|
35 mcg/mL
Standard Deviation 0.6
|
37 mcg/mL
Standard Deviation 0.7
|
|
Serum Iron Concentration
Day 14
|
34 mcg/mL
Standard Deviation 0.5
|
34 mcg/mL
Standard Deviation 0.7
|
|
Serum Iron Concentration
Day 21
|
34 mcg/mL
Standard Deviation 0.6
|
40 mcg/mL
Standard Deviation 0.6
|
|
Serum Iron Concentration
Day 28
|
37 mcg/mL
Standard Deviation 0.5
|
36 mcg/mL
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28Outcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Serum Ferritin Concentration
Day 7
|
280 ng/mL
Standard Deviation 46
|
265 ng/mL
Standard Deviation 73
|
|
Serum Ferritin Concentration
Day 14
|
268 ng/mL
Standard Deviation 51
|
268 ng/mL
Standard Deviation 80
|
|
Serum Ferritin Concentration
Day 21
|
251 ng/mL
Standard Deviation 40
|
355 ng/mL
Standard Deviation 83
|
|
Serum Ferritin Concentration
Day 28
|
383 ng/mL
Standard Deviation 54
|
361 ng/mL
Standard Deviation 76
|
PRIMARY outcome
Timeframe: Day 7, Day 14, Day 21, Day 28Outcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Erythrocyte Zinc Protoporphyrin Concentration
Day 7
|
69 micromol:mol heme
Standard Deviation 4
|
67 micromol:mol heme
Standard Deviation 5
|
|
Erythrocyte Zinc Protoporphyrin Concentration
Day 14
|
75 micromol:mol heme
Standard Deviation 6
|
77 micromol:mol heme
Standard Deviation 5
|
|
Erythrocyte Zinc Protoporphyrin Concentration
Day 21
|
86 micromol:mol heme
Standard Deviation 5
|
91 micromol:mol heme
Standard Deviation 6
|
|
Erythrocyte Zinc Protoporphyrin Concentration
Day 28
|
84 micromol:mol heme
Standard Deviation 6
|
89 micromol:mol heme
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital
|
29 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission
|
45 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Instance of Drug-related Constipation Throughout Hospital Admission
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Average Number of Days That Subjects Were Taking Antibiotics
|
14 days
Standard Deviation 2
|
16 days
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Throughout hospital stay up to 6 weeksOutcome measures
| Measure |
Iron Group
n=97 Participants
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 Participants
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Average Length of Stay in the Hospital
|
14 days
Standard Deviation 1
|
16 days
Standard Deviation 2
|
Adverse Events
Iron Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Iron Group
n=97 participants at risk
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.
Ferrous Sulfate: Iron group
|
Placebo Group
n=103 participants at risk
Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
Placebo Oral Tablet: Placebo group
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal upset
|
7.2%
7/97
|
3.9%
4/103
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place