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

NCT04610827 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20-007655
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Ferritin Level

  Ferritin level in blood measured in micrograms per liter

  2 months

• Side Effects

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

  2 months

Study Arms (3)

Ferrous sulfate daily

ACTIVE COMPARATOR

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

Drug: Ferrous sulfate

Ferrous sulfate twice daily

ACTIVE COMPARATOR

Subjects will take 1.5 mg/kg oral iron twice daily

Drug: Ferrous sulfate

Ferrous sulfate every other day

ACTIVE COMPARATOR

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

Drug: Ferrous sulfate

Interventions

Ferrous sulfate DRUG

Guideline-recommended 3 mg/kg/day dosing

Ferrous sulfate daily; Ferrous sulfate every other day; Ferrous sulfate twice daily

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Wake Disorders; Restless Legs Syndrome; Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Study terminated due to change in personnel and lack of resources to continue.

Results Point of Contact

• Title: Julie M. Baughn, M.D.
• Organization: Mayo Clinic

Baughn.Julie@mayo.edu

507-293-1031

Study Officials

• Julie Baughn, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: November 16, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: May 22, 2024
• Results First Posted: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)