Impact of Iron Supplementation Treatment on Brain Iron Concentrations
Key facts
- Who runs it
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Where
- Baltimore, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 12 people enrolled
- Started
- 15 Sept 2022
- Ended
- 30 Jun 2025
- Type of study
- Observational
- Treatments tested
- ferrous sulfate
- Record updated
- 14 October 2025
Who can take part
- Age
- 5 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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%
Who cannot take part
- child has been receiving iron supplementation, psychostimulant treatment, or a dopamine agonist within the past 6 months
- 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
- family is not proficient in English language
- child is in foster care
Where in United States
- Kennedy Krieger InstituteBaltimore, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- ADHD+RLS
Twelve participants between the ages of 5 and 18 years with a clinical diagnosis of either RLS or ADHD, and iron deficiency.
Treatment: ferrous sulfate
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Iron Supplementation Treatment on Brain Iron Concentrations Among Children With ADHD & Restless Leg Syndrome Combined With Periodic Limb Movements in Sleep
- Record updated
- 14 October 2025