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

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Iron-deficiency; Sleep Disorder; Restless Legs Syndrome; Periodic Limb Movement Sleep Disorder

Treatments: Drug: Ferrous sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04610827

20-007655

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Ferrous sulfate daily

Active Comparator group

Description:

Subject will take 3 mg/kg oral iron in the morning

Treatment:

Drug: Ferrous sulfate

Ferrous sulfate twice daily

Active Comparator group

Description:

Subjects will take 1.5 mg/kg oral iron twice daily

Treatment:

Drug: Ferrous sulfate

Ferrous sulfate every other day

Active Comparator group

Description:

6 mg/kg oral iron every other day in the morning

Treatment:

Drug: Ferrous sulfate