Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Phase 4

Terminated

• Conditions: Sleep Disorder; Restless Legs Syndrome; Periodic Limb Movement Sleep Disorder; Iron-deficiency
• Interventions: Drug: Ferrous sulfate

• Registration Number: NCT04610827
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Study Start: 2020-11-16
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Results First Submitted: 2024-04-26
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Results First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous sulfate daily	Ferrous sulfate	Subject will take 3 mg/kg oral iron in the morning
Ferrous sulfate twice daily	Ferrous sulfate	Subjects will take 1.5 mg/kg oral iron twice daily
Ferrous sulfate every other day	Ferrous sulfate	6 mg/kg oral iron every other day in the morning

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States