A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: ADHD, Sleep Problems

In brief

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

Key facts

Study ID

NCT07061470

Run by

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

People needed

70

Starts

2027-03-01

Expected to finish

2027-07-31

Last updated by the study team

2026-05-04

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinically diagnosed with ADHD
• have blood ferritin level below 50ng/mL
• have parent- or self-reported restless sleep

You may not qualify if…

• presence of any chronic medical or genetic condition that could impact iron metabolism
• presence of moderate to severe Obstructive Sleep Apnea
• having received Iron supplementation treatment within the past 3 months
• having blood ferritin level indicative of anemia that requires immediate treatment

Where it is running

• Kennedy Krieger Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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