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

January 6, 2023 updated by: Julie M. Baughn, Mayo Clinic

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ferritin level
Time Frame: Baseline, 2 months
Ferritin level in blood measured in micrograms per liter
Baseline, 2 months
Side effects
Time Frame: 2 months
Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Julie Baughn, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-007655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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