Trial Outcomes & Findings for Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder (NCT NCT04610827)
NCT ID: NCT04610827
Last Updated: 2024-05-22
Results Overview
Ferritin level in blood measured in micrograms per liter
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
2 months
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
Ferrous Sulfate Daily
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ferrous Sulfate Daily
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ferrous Sulfate Daily
n=1 Participants
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
n=2 Participants
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
n=3 Participants
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Ferritin level at 2 months was not collected for 4 participants.
Ferritin level in blood measured in micrograms per liter
Outcome measures
| Measure |
Ferrous Sulfate Daily
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
n=1 Participants
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
n=1 Participants
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
|---|---|---|---|
|
Ferritin Level
|
—
|
24 mcg/L
|
19 mcg/L
|
PRIMARY outcome
Timeframe: 2 monthsNumber of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
Outcome measures
| Measure |
Ferrous Sulfate Daily
n=1 Participants
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
n=2 Participants
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
n=3 Participants
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
|---|---|---|---|
|
Side Effects
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Ferrous Sulfate Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ferrous Sulfate Twice Daily
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ferrous Sulfate Every Other Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ferrous Sulfate Daily
n=1 participants at risk
Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Twice Daily
n=2 participants at risk
Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
Ferrous Sulfate Every Other Day
n=3 participants at risk
6 mg/kg oral iron every other day in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/GI Upset
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study participation for a total of approximately 2 months after starting ferrous sulfate on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place