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

Primary Purpose

Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder

Status

Enrolling by invitation

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ferrous sulfate

About this trial

This is an interventional treatment trial for Sleep Disorder

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Ferrous sulfate daily

Ferrous sulfate twice daily

Ferrous sulfate every other day

Arm Description

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

Subjects will take 1.5 mg/kg oral iron twice daily

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

Outcomes

Primary Outcome Measures

Change in ferritin level

Ferritin level in blood measured in micrograms per liter

Side effects

Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)

Secondary Outcome Measures

Full Information

NCT ID

NCT04610827

First Posted

October 26, 2020

Last Updated

January 6, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04610827

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

November 16, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorder, Restless Legs Syndrome, Periodic Limb Movement Sleep Disorder, Iron-deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ferrous sulfate daily

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ferrous sulfate twice daily

Arm Type

Active Comparator

Arm Description

Subjects will take 1.5 mg/kg oral iron twice daily

Arm Title

Ferrous sulfate every other day

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ferrous sulfate

Intervention Description

Guideline-recommended 3 mg/kg/day dosing

Primary Outcome Measure Information:

Title

Change in ferritin level

Description

Ferritin level in blood measured in micrograms per liter

Time Frame

Baseline, 2 months

Title

Side effects

Description

Number of subjects to experience side effects effects (e.g., stool color change, nausea, constipation, teeth staining)

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Baughn, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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