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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-18
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

About this trial

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

Eligibility criteria

Qualifiers

clinically diagnosed with ADHD

have blood ferritin level below 50ng/mL

have parent- or self-reported restless sleep

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ferrous Sulfate
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups