Impact of Iron Supplementation Treatment on Brain Iron Concentrations

Description

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

Study Overview

Study Details

Study overview

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.

Impact of Iron Supplementation Treatment on Brain Iron Concentrations Among Children With ADHD & Restless Leg Syndrome Combined With Periodic Limb Movements in Sleep

Impact of Iron Supplementation Treatment on Brain Iron Concentrations

Condition
ADHD
Intervention / Treatment

-

Contacts and Locations

Baltimore

Kennedy Krieger Institute, Baltimore, Maryland, United States, 21231

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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%
  • * 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.

Ages Eligible for Study

5 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Alison E Pritchard, PhD, PRINCIPAL_INVESTIGATOR, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Record Dates

2025-06-30