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

Sleep Disorder Clinical Trial

Official title:

Optimum Frequency and Timing of Oral Iron Administration for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04610827
• Other study ID #: 20-007655
• Status: Terminated
• Phase: Phase 4
• Start date: November 16, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iron-deficiency
• Movement Disorders
• Nocturnal Myoclonus Syndrome
• Parasomnias
• Periodic Limb Movement Sleep Disorder
• Psychomotor Agitation
• Restless Legs Syndrome
• Sleep Disorder
• Sleep Wake Disorders
• Syndrome

Intervention

Drug:
• Ferrous sulfate
Guideline-recommended 3 mg/kg/day dosing

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ferritin Level	Ferritin level in blood measured in micrograms per liter	2 months
Primary	Side Effects	Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)	2 months

External Links

•   Mayo Clinic Clinical Trials