Back to search results

Iron Supplementation for Youth With ADHD and Restless Sleep

This study is looking into whether iron supplementation can help young people with ADHD who also experience restless sleep. Researchers want to see if taking Ferrous Sulfate (an iron supplement) for 3 months improves sleep difficulties and ADHD symptoms compared to a placebo (a pill with no active medicine). You might be able to join if you are between 8 and 18 years old, have an ADHD diagnosis, and have low iron levels (blood ferritin below 50ng/mL) along with restless sleep. The main goal is to see if iron supplementation improves sleep efficiency, which will be measured nightly for two weeks before and after treatment. The study is planning to enroll 70 participants, but its current recruitment status is unclear.

Study design
This study is a double-blind, placebo-controlled randomized trial, meaning neither you nor the study team will know if you are receiving Ferrous Sulfate or a placebo. Seventy participants will be assigned to either the treatment or control group.
What's involved
You would take either Ferrous Sulfate or a placebo for 3 months. Your sleep efficiency will be measured nightly for two weeks before treatment and again for two weeks at the end of treatment.
Compensation
Not stated in the trial record.
Follow-up
Sleep efficiency will be assessed for two weeks at the end of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07061470

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

Not Yet Recruiting
PHASE1Ages 8–18InterventionalTreatment
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
~70 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Ferrous SulfatePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep Efficiency
Measured over Sleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.

Conditions

ADHD
Sleep Problems

Explore related trials

Attention Deficit Hyperactivity DisorderDyssomniaFerritin

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Alison E Pritchard, PhD · PRINCIPAL_INVESTIGATOR · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Who to contact

Alison E Pritchard, PhD
[email protected]
443-904-2488
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Sleep EfficiencySleep efficiency will be assessed nightly for 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.

    Sleep efficiency refers to the proportion of time in bed spent sleeping and is measured via actigraphy monitoring. Higher scores indicate more efficient/better sleep.