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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

Study 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 Legs Syndrome
  • Sleep Disorders
  • Periodic Limb Movement Disorder
  • Iron-Deficiency Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ferritin level
Side effects

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
3,206 Previous Clinical Trials
3,767,023 Total Patients Enrolled
1 Trials studying Restless Legs Syndrome
8 Patients Enrolled for Restless Legs Syndrome
Suresh Kotagal, MDPrincipal InvestigatorMayo Clinic
Julie Baughn, MDPrincipal InvestigatorMayo Clinic

Media Library

Ferrous Sulfate (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04610827 — Phase 4
Restless Legs Syndrome Research Study Groups: Ferrous sulfate daily, Ferrous sulfate every other day, Ferrous sulfate twice daily
Restless Legs Syndrome Clinical Trial 2023: Ferrous Sulfate Highlights & Side Effects. Trial Name: NCT04610827 — Phase 4
Ferrous Sulfate (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04610827 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met to qualify for enrollment in this experiment?

"To meet the eligibility criteria of this clinical trial, candidates must have a diagnosis of restless legs syndrome and be between two to eight years old. The research team aims to recruit 60 participants in total."

Answered by AI

What is the typical purpose of a daily dose of ferrous sulfate?

"Ferrous sulfate is a common remedy for folic acid insufficiency, as well as hypochromic anemia, breastfeeding women, and iron deficiency anemia."

Answered by AI

Is this research opportunity still available to those seeking treatment?

"According to information available on clinicaltrials.gov, this trial is not presently enrolling new patients. Originally uploaded in November of 2020, the most recent update was recorded in December 2021 and no further recruitment will take place at present time; however, there are still 2519 other trials that are actively recruiting participants."

Answered by AI

Does this research encompass individuals over the age of fifty-five?

"Per the requirements of this research protocol, only children between 2 and 8 years old are eligible for enrollment."

Answered by AI

How many volunteers are enrolled in this scientific experiment?

"This medical trial has now reached its completion and is no longer seeking participants. Initially posted on November 16th 2020, the last update was made just days ago on December 30th 2021. If you are searching for alternate studies, 2507 trials concerning Restless Legs Syndrome and 12 experiments related to Ferrous Sulfate Daily remain open for recruitment."

Answered by AI

What adverse effects may arise from regular ingestion of Ferrous sulfate?

"Ferrous sulfate has been approved by the relevant governing body, so it received a rating of 3 for safety."

Answered by AI

Can you provide insight into the other investigations that have examined Ferrous sulfate administration?

"Currently, 12 research studies on Ferrous sulfate daily are ongoing with 4 trials in their final phase. Multiple sites around the country are participating, including 40 locations based near Galveston, Texas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder
Julie M. Baughn 2020. "Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04610827.
~14 spots leftby Apr 2025
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