Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
Who is this study for? Patients with Sleep Disorder, Restless Legs Syndrome
What treatments are being studied? Ferrous Sulfate
Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 10
Healthy Volunteers: f
View:
• 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.
Locations
United States
Minnesota
Mayo Clinic in Rochester
Rochester
Time Frame
Start Date: 2020-11-16
Completion Date: 2021-06-29
Participants
Target number of participants: 6
Treatments
Active_comparator: Ferrous sulfate daily
Subject will take 3 mg/kg oral iron in the morning
Active_comparator: Ferrous sulfate twice daily
Subjects will take 1.5 mg/kg oral iron twice daily
Active_comparator: Ferrous sulfate every other day
6 mg/kg oral iron every other day in the morning
Authors
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic