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
clinically diagnosed with ADHD
have blood ferritin level below 50ng/mL
have parent- or self-reported restless sleep
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
Parallel
Ferrous Sulfate
Dietary supplementDosing of the iron supplement will be based on weight.
Placebo
Other interventionPlacebo pills will be provided to participants in the placebo arm
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.
Total sleep time
Total sleep time in minutes as measured by actigraphy. Higher scores indicate more time asleep.
Wake after sleep onset
Number of minutes spent awake between falling asleep at night and getting up in the morning, as measured by actigraphy. Higher scores on this measure are indicative of greater difficulty staying asleep through the night.
Latency to sleep onset
Number of minutes from laying down in bed for the night to falling asleep, measured by actigraphy. Higher scores on this measure will indicate longer times to fall asleep.
Attention Deficit Hyperactivity Disorder-Rating Scale-V, parent version
Parent rating of child's ADHD symptoms; raw scores will be calculated by summing all items and will range from 0-54; higher scores indicate more severe ADHD symptoms.
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This trial is not recruiting at the moment. You can still explore other options:
