A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep
Key facts
- Where
- Baltimore, United StatesSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Source: NCT07061470, who can take part
Where in United States
- Kennedy Krieger InstituteBaltimore, United StatesContact: Alison E Pritchard, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Trial code
- NCT07061470
- Record updated
- 4 May 2026
- Original description
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:Read full original descriptionShow less
RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit/Hyperactivity Disorder, Phase II
The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:
Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo?
Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.
Participants will:
* Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment
Inclusion: clinically diagnosed with ADHD; have blood ferritin level below 50ng/mL; have parent- or self-reported restless sleep.
Exclusion: having received Iron supplementation treatment within the past 3 months; presence of any chronic medical or genetic condition that could impact iron metabolism; presence of moderate to severe Obstructive Sleep Apnea; having blood ferritin level indicative of anemia that requires immediate treatment.