Trial Outcomes & Findings for Alternate Day Versus Daily Oral Iron Therapy in Adolescents (NCT NCT05007899)
NCT ID: NCT05007899
Last Updated: 2023-09-13
Results Overview
Percentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
At enrollment
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Daily
Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
|
Alternate Day
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Baseline characteristics by cohort
| Measure |
Daily
n=7 Participants
Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
|
Alternate Day
n=6 Participants
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13 Years
n=99 Participants
|
16 Years
n=107 Participants
|
14 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
PBAC Score
|
455 Scores of a scale
n=99 Participants
|
144 Scores of a scale
n=107 Participants
|
325 Scores of a scale
n=206 Participants
|
|
Hemoglobin (g/dL)
|
6.8 g/dL
n=99 Participants
|
5.7 g/dL
n=107 Participants
|
6.3 g/dL
n=206 Participants
|
|
Post transfusions hemoglobin (g/dL)
|
8.4 g/dL
n=99 Participants
|
7.7 g/dL
n=107 Participants
|
8.2 g/dL
n=206 Participants
|
|
Mean Corpuscular volume (MCV, fL)
|
80.8 fl
n=99 Participants
|
74.9 fl
n=107 Participants
|
78.5 fl
n=206 Participants
|
|
Serum ferritin (ng/mL)
|
4 ng/mL
n=99 Participants
|
9.5 ng/mL
n=107 Participants
|
5 ng/mL
n=206 Participants
|
PRIMARY outcome
Timeframe: At enrollmentPercentage of eligible patients who consent to be enrolled in the study. A secure screening and enrollment log will be kept. Each screened patient will be categorized as either: ineligible, eligible but not approached, eligible and enrolled, eligible and declined. If the latter (eligible and declined), the reason for declining will also be obtained and noted in the study log.
Outcome measures
| Measure |
All Eligible Patients
n=20 Participants
Primary outcome was the percentage of eligible patients approached for the study who consented to enroll.
|
Alternate Day
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Percentage of Eligible Patients Enrolled.
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: At enrollmentPercentage of patients who continue in study as compared to total number of enrolled patients. Information will be obtained from the study log.
Outcome measures
| Measure |
All Eligible Patients
n=7 Participants
Primary outcome was the percentage of eligible patients approached for the study who consented to enroll.
|
Alternate Day
n=6 Participants
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Percentage of Enrolled Patients Who Agree to Continue in the Study After Randomization
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPercentage of enrolled patients that completed 12 weeks of the study.
Outcome measures
| Measure |
All Eligible Patients
n=7 Participants
Primary outcome was the percentage of eligible patients approached for the study who consented to enroll.
|
Alternate Day
n=6 Participants
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Retention as Measured by Visit Follow-up Adherence
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 week study visitPill counts were performed as an objective measure of adherence. Subjects were given a specific number of pills for the duration of the study. At the 12 week visit they were asked to return any remaining pills, which were then counted and compared to the number of expected pills should be remaining, assuming 100% adherence. These numbers were used to calculate an estimate of adherence.
Outcome measures
| Measure |
All Eligible Patients
n=7 Participants
Primary outcome was the percentage of eligible patients approached for the study who consented to enroll.
|
Alternate Day
n=6 Participants
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Adherence
|
65 % of pills consumed
Interval 31.0 to 100.0
|
0 % of pills consumed
Interval 0.0 to 0.0
|
Adverse Events
Daily
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Alternate Day
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daily
n=5 participants at risk
Patients receive standard regimen of ferrous sulfate 325 mg (65 mg elemental iron) once every morning.
|
Alternate Day
n=2 participants at risk
Patients receive ferrous sulfate 325 mg (65 mg elemental iron) once every other morning.
|
|---|---|---|
|
Gastrointestinal disorders
Heartburn
|
60.0%
3/5 • Number of events 3 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
50.0%
1/2 • Number of events 1 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
3/5 • Number of events 3 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
0.00%
0/2 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
0.00%
0/2 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
0.00%
0/2 • Twelve weeks
All-Cause Mortality, Serious Adverse Events, and Other (Gastrointestinal) Adverse Events were collected at the 12 week visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place