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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610827
Recruitment Status : Enrolling by invitation
First Posted : November 2, 2020
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Julie M. Baughn, Mayo Clinic

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 16, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change in ferritin level [ Time Frame: Baseline, 2 months ]
    Ferritin level in blood measured in micrograms per liter

  2. Side effects [ Time Frame: 2 months ]
    Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610827


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Julie Baughn, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Julie M. Baughn, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04610827    
Other Study ID Numbers: 20-007655
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Psychomotor Agitation
Restless Legs Syndrome
Movement Disorders
Nocturnal Myoclonus Syndrome
Disease
Syndrome
Pathologic Processes
 Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Central Nervous System Diseases