Impact of Iron Supplementation Treatment on Brain Iron Concentrations

Launched by HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC. · Oct 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how iron supplementation—taking iron supplements—can affect brain iron levels and potentially improve symptoms in children with Attention Deficit Hyperactivity Disorder (ADHD) and Restless Legs Syndrome (RLS), including related sleep issues. The researchers aim to understand if increasing iron in the brain can help alleviate symptoms like restlessness and inattention in children aged 10 to 15 years who have low iron levels.

To participate, children must have a diagnosis of both ADHD and RLS, show signs of periodic limb movement during sleep, and have low iron levels in their blood. During the study, participants will undergo two MRI scans, wear a device to monitor their sleep for five nights, and complete questionnaires about their symptoms—once before starting iron supplements and again after three months. This trial is currently recruiting participants, and it's important to note that children with certain medical conditions or who have been receiving specific treatments recently may not be eligible.

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Eligibility criteria

• Inclusion 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%
• Exclusion Criteria:
• • 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.