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

NCT07061470 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IRB00511528
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ADHD; Sleep Problems

Keywords

ADHD; iron supplements; sleep; restlessness; attention; restless legs syndrome

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency

  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.

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

Secondary Outcomes (11)

• Total sleep time

  These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.

• Wake after sleep onset

  These will be assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.

• Latency to sleep onset

  Assessed nightly for a period of 2 weeks before treatment begins and then again for 2 weeks at the end of treatment.

• Attention Deficit Hyperactivity Disorder-Rating Scale-V, parent version

  Completed at baseline and again within 2 weeks post-treatment.

• Attention Deficit Hyperactivity Disorder-Rating Scale-V, self report

  Completed at baseline and again within 2 weeks post-treatment.

Study Arms (2)

Iron supplementation arm

EXPERIMENTAL

Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment

Dietary Supplement: Ferrous Sulfate

Placebo arm

PLACEBO COMPARATOR

Participants in the placebo arm will receive 3 months of placebo treatment

Other: Placebo

Interventions

Ferrous Sulfate DIETARY_SUPPLEMENT

Dosing of the iron supplement will be based on weight.

Iron supplementation arm

Placebo OTHER

Placebo pills will be provided to participants in the placebo arm

Placebo arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Parasomnias; Psychomotor Agitation; Restless Legs Syndrome

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Alison E Pritchard, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison E Pritchard, PhD

CONTACT

443-904-2488; pritchard@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 11, 2025
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)