Evaluating how iron supplementation affects brain iron levels and symptoms in children with ADHD and RLS
Impact of Iron Supplementation Treatment on Brain Iron Concentrations Among Children With ADHD & Restless Leg Syndrome Combined With Periodic Limb Movements in Sleep
This study is testing if giving iron supplements to children with ADHD and Restless Legs Syndrome can improve their symptoms and brain iron levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04144790 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of iron supplementation on brain iron concentrations and its potential role in alleviating symptoms of ADHD and Restless Legs Syndrome (RLS) in children aged 10 to 15 years. Participants will undergo a 7 Tesla MRI scan and complete symptom assessments before and after a 3-month iron supplementation treatment with ferrous sulfate. The study will explore the relationship between changes in brain iron levels and improvements in ADHD and RLS symptoms, providing novel insights into the role of iron in these conditions.
Who should consider this trial
Good fit: Ideal candidates are children aged 10 to 15 years with clinical diagnoses of ADHD and RLS, along with specific iron deficiency criteria.
Not a fit: Patients with chronic medical conditions affecting iron metabolism or those currently receiving treatments for ADHD or RLS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children suffering from ADHD and RLS by highlighting the importance of iron supplementation.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated potential benefits of iron supplementation in managing symptoms of ADHD and RLS.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Alison E Pritchard, PhD — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study coordinator: Alison E Pritchard, PhD
- Email: pritchard@kennedykrieger.org
- Phone: 443-923-4409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.