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

NCT07061470 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Ferrous Sulfate

Dosing of the iron supplement will be based on weight.

OTHER

Placebo

Placebo pills will be provided to participants in the placebo arm

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061470 on ClinicalTrials.gov