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

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04610827

Collaborator

(none)

Enrollment

Location

Arms

36.5

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder Restless Legs Syndrome Periodic Limb Movement Sleep Disorder Iron-deficiency	Drug: Ferrous sulfate	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ferrous sulfate daily Subject will take 3 mg/kg oral iron in the morning	Drug: Ferrous sulfate Guideline-recommended 3 mg/kg/day dosing
Active Comparator: Ferrous sulfate twice daily Subjects will take 1.5 mg/kg oral iron twice daily	Drug: Ferrous sulfate Guideline-recommended 3 mg/kg/day dosing
Active Comparator: Ferrous sulfate every other day 6 mg/kg oral iron every other day in the morning	Drug: Ferrous sulfate Guideline-recommended 3 mg/kg/day dosing

Arm

Intervention/Treatment

Active Comparator: Ferrous sulfate daily

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

Drug: Ferrous sulfate

Guideline-recommended 3 mg/kg/day dosing

Active Comparator: Ferrous sulfate twice daily

Subjects will take 1.5 mg/kg oral iron twice daily

Drug: Ferrous sulfate

Guideline-recommended 3 mg/kg/day dosing

Active Comparator: Ferrous sulfate every other day

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

Drug: Ferrous sulfate

Guideline-recommended 3 mg/kg/day dosing

Outcome Measures

Primary Outcome Measures

Change in ferritin level [Baseline, 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
Age 2 to 8 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 refluex 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.