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Iron Supplement
Ferrous Sulfate for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
Phase 4
Waitlist Available
Led By Suresh Kotagal, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will compare different frequencies of oral iron given to children with restless leg syndrome/periodic limb movement disorder to see if there is a difference in serum ferritin levels.
Eligible Conditions
- Restless Leg Syndrome
- Anemia
- Restless Legs Syndrome
- Sleep Disorders
- Periodic Limb Movement Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ferritin Level
Side Effects
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Ferrous sulfate dailyActive Control1 Intervention
Subject will take 3 mg/kg oral iron in the morning
Group II: Ferrous sulfate every other dayActive Control1 Intervention
6 mg/kg oral iron every other day in the morning
Group III: Ferrous sulfate twice dailyActive Control1 Intervention
Subjects will take 1.5 mg/kg oral iron twice daily
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,118 Total Patients Enrolled
Suresh Kotagal, MDPrincipal InvestigatorMayo Clinic
Julie Baughn, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not received treatment for obstructive sleep apnea.You have a gastrointestinal disorder, like acid reflux or celiac disease.You have had surgery on your stomach or intestines, or have a feeding tube in place.You are currently taking medications for heartburn or acid reflux.You have inflammatory conditions like juvenile idiopathic arthritis or inflammatory bowel disease.Your ferritin level is 24 mcg/L or lower in a blood test from the last 30 days.You must be between 2 and 8 years old.You have been diagnosed with restless leg syndrome, periodic limb movement disorder, or sleep problems.
Research Study Groups:
This trial has the following groups:- Group 1: Ferrous sulfate daily
- Group 2: Ferrous sulfate every other day
- Group 3: Ferrous sulfate twice daily
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.