Impact of Iron Supplementation Treatment on Brain Iron Concentrations

NCT04144790 | Completed

• 1 other identifier: KKI
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the present study is to provide novel data to evaluate brain iron concentration as a mediator of the association between iron supplementation treatment and improvement in symptoms of ADHD and RLS in children, including PLMS. Twelve participants between the ages of 10 and 15 years will be recruited via Kennedy Krieger Institute's Sleep Disorders Clinic. Eligible participants will be asked to complete, at baseline (pre-iron supplementation treatment) and again at follow-up (post-treatment): 1) a 7 Tesla MRI scan, 2) five consecutive nights of RestEaZe™ monitoring, 3) caregiver-reported (or patient-reported if over the age of 10 years) International Restless Leg Syndrome Scale (IRLSS), and 4) caregiver-reported ADHD Rating Scale-5. The treatment interval will be 3 months.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in ADHD symptoms

  Change in ADHD symptoms measured by parent-reported ADHD-RS-V

  Change from pre- to post- 3 months of iron supplementation treatment

• Change in RLS symptoms

  Change in RLS symptoms measured by and RestEaZe™ monitors

  Change from pre- to post- 3 months of iron supplementation treatment

Secondary Outcomes (2)

• Change in brain-based iron concentrations

  Change from pre- to post- 3 months of iron supplementation treatment

• Change in blood-based iron concentrations

  Change from pre- to post- 3 months of iron supplementation treatment

Study Arms (1)

ADHD+RLS

Twelve participants between the ages of 5 and 18 years with a clinical diagnosis of either RLS or ADHD, and iron deficiency.

Dietary Supplement: ferrous sulfate

Interventions

ferrous sulfate DIETARY_SUPPLEMENT

Although established guidelines do not currently exist for iron supplementation for children, studies have demonstrated effectiveness of a 3-month treatment regimen of 5mg/kg per day of orally-administered ferrous sulfate in reducing PLMS and subjective RLS symptoms and in increasing serum ferritin levels. Ferrous sulfate 80 mg/day resulted in improvement of ADHD symptoms in iron-deficient children.

ADHD+RLS

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twelve participants between the ages of 5 and 18 years will be recruited via Kennedy Krieger Institute's Sleep Disorders Clinic. Recruitment will be accomplished by posting flyers with study information at the clinic and by asking Sleep Disorders Clinic clinicians to discuss the study with their patients who may be eligible and their caregivers.

You may qualify if:

• a clinical diagnosis of RLS
• a clinical diagnosis of ADHD
• PLMS \> 3/hour, based on average of 5 nights of home recording with RestEaze leg meters
• fasting serum iron values with ferritin \< 50 mcg/kg and transferrin saturation \< 45%

You may not qualify if:

• family is not proficient in English language
• child is in foster care
• child has a chronic medical condition or genetic/metabolic disorder that might impact iron metabolism
• child has another sleep disorder or neuropsychiatric condition that might influence sleep, RLS, or ADHD symptoms
• child has been receiving iron supplementation, psychostimulant treatment, or a dopamine agonist within the past 6 months.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Anemia, Iron-Deficiency; Restless Legs Syndrome

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias

Study Officials

• Alison E Pritchard, PhD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 30, 2019
• Study Start: September 15, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)