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

Phase 4TerminatedNCT04610827

Mayo Clinic6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disorder Restless Legs Syndrome Periodic Limb Movement Sleep Disorder Iron-deficiency

Interventions

Ferrous sulfateDRUG

Guideline-recommended 3 mg/kg/day dosing

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Ferritin Level

Ferritin level in blood measured in micrograms per liter

Time frame: 2 months

Side Effects

Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)

Time frame: 2 months

Data from ClinicalTrials.gov

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