Impact of Iron Supplementation Treatment on Brain Iron Concentrations (NCT04144790) | Clinical Trial Compass
CompletedNot Applicable
Impact of Iron Supplementation Treatment on Brain Iron Concentrations
United States12 participantsStarted 2022-09-15
Plain-language 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.
Who can participate
Age range
5 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in ADHD symptoms
Timeframe: Change from pre- to post- 3 months of iron supplementation treatment
2
Change in RLS symptoms
Timeframe: Change from pre- to post- 3 months of iron supplementation treatment
Trial details
NCT IDNCT04144790
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.