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Iron pills tested as a simple fix for restless sleep in children with ADHD

NCT ID NCT07061470

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether daily iron supplements can improve restless sleep and ADHD symptoms in 70 children with ADHD who have low iron levels. Participants will take either iron or a placebo for 3 months, and their sleep and attention will be measured using motion-sensing leg bands and questionnaires. The goal is to see if a simple, over-the-counter supplement can make a real difference.

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, over-the-counter iron supplement to ease restless sleep and ADHD symptoms in children with low iron levels.
What could go wrong
This is an early phase 1/2 trial with only 70 participants. The supplement may not improve sleep or ADHD more than a placebo, and results may not apply to all children with ADHD.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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.

Ages

8 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: * clinically diagnosed with ADHD * have blood ferritin level below 50ng/mL * have parent- or self-reported restless sleep Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder Parasomnias Psychomotor Agitation restless legs syndrome

As listed by the trial registrant

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

ADHD Sleep problems

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21231, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.