Iron-deficiency, Periodic Limb Movement Sleep Disorder, Restless Legs Syndrome, Sleep Disorder
Conditions
Brief summary
The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.
Interventions
DRUGFerrous sulfate
Guideline-recommended 3 mg/kg/day dosing
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days. * Age 2 to 10 years. * Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.
Exclusion criteria
* Currently taking oral formulation of iron other than a multivitamin. * Untreated obstructive sleep apnea. * Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease. * Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube. * Use of H2 blocker, antacid, or proton pump inhibitor. * Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease. * Elevated CRP at time of initial ferritin or report of illness in past 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin Level | 2 months | Ferritin level in blood measured in micrograms per liter |
| Side Effects | 2 months | Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferrous Sulfate Daily Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing | 1 |
| Ferrous Sulfate Twice Daily Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate: Guideline-recommended 3 mg/kg/day dosing | 2 |
| 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 | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Ferrous Sulfate Twice Daily | Ferrous Sulfate Every Other Day | Ferrous Sulfate Daily |
|---|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 6 participants | 2 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 3 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 1 | 1 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Ferritin Level
Ferritin level in blood measured in micrograms per liter
Time frame: 2 months
Population: Ferritin level at 2 months was not collected for 4 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferrous Sulfate Twice Daily | Ferritin Level | 24 mcg/L |
| Ferrous Sulfate Every Other Day | Ferritin Level | 19 mcg/L |
Primary
Side Effects
Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ferrous Sulfate Daily | Side Effects | 1 Participants |
| Ferrous Sulfate Twice Daily | Side Effects | 1 Participants |
| Ferrous Sulfate Every Other Day | Side Effects | 0 Participants |