Could iron pills ease ADHD and restless legs in children?

NCT ID NCT04144790

Symptom relief Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving iron supplements to children with ADHD, restless legs syndrome, and low iron levels could improve their symptoms. Twelve kids aged 10-15 took iron for 3 months. Researchers measured changes in brain iron, blood iron, and symptoms using sleep monitors and parent reports.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ferrous sulfate (iron supplement)
What this could lead to: If it works, this could point toward a simple iron supplement as a way to ease ADHD and restless legs symptoms in children with low iron.
What could go wrong: This is a very small, completed study with only 12 children. Results may not apply to all kids, and iron supplements can cause stomach upset or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Sep 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Twelve participants between the ages of 5 and 18 years will be recruited via Kennedy Krieger Institute's Sleep Disorders Clinic. Recruitment will be accomplished by posting flyers with study information at the clinic and by asking Sleep Disorders Clinic clinicians to discuss the study with their patients who may be eligible and their caregivers.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder iron deficiency anemia periodic limb movement disorder restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADHD Iron-deficiency Periodic limb movement sleep disorder Restless legs syndrome

Could iron pills ease ADHD and restless legs in children?

What the study statuses mean