Randomized, Placebo-Controlled Trial of Ferrous Sulfate to Treat Insomnia in Children With Autism Spectrum Disorders.

Publication date: Mar 01, 2020

Insomnia and low iron stores are common in children with autism spectrum disorders, and low iron stores have been associated with sleep disturbance.

We performed a randomized placebo-controlled trial of oral ferrous sulfate to treat insomnia in children with autism spectrum disorders and low normal ferritin levels. Twenty participants who met inclusion criteria and whose insomnia did not respond to sleep education were randomized to 3 mg/kg/day of ferrous sulfate (n = 9) or placebo (n = 11) for three months.

Iron supplementation was well tolerated, and no serious adverse events were reported. Iron supplementation improved iron status (+18.4 ng/mL active versus -1.6 ng/mL placebo, P = 0.044) but did not significantly improve the primary outcome measures of sleep onset latency (-11.0 minutes versus placebo, 95% confidence interval -28.4 to 6.4 minutes, P = 0.22) and wake time after sleep onset (-7.7 minutes versus placebo, 95% confidence interval -22.1 to 6.6 min, P = 0.29) as measured by actigraphy. Iron supplementation was associated with improvement in the overall severity score from the Sleep Clinical Global Impression Scale (-1.5 points versus placebo, P = 0.047). Changes in measures of daytime behavior did not differ between groups.

This trial demonstrated no improvement in primary outcome measures of insomnia in subjects treated with ferrous sulfate compared with placebo. Interpretation was limited by low enrollment.

Reynolds, A.M., Connolly, H.V., Katz, T., Goldman, S.E., Weiss, S.K., Halbower, A.C., Shui, A.M., Macklin, E.A., Hyman, S.L., and Malow, B.A. Randomized, Placebo-Controlled Trial of Ferrous Sulfate to Treat Insomnia in Children With Autism Spectrum Disorders. 15361. 2020 Pediatr Neurol (104):

Concepts Keywords
Autism Spectrum Disorders Autism
Confidence Interval Placebo
Ferritin Iron supplement
Ferrous Sulfate Sleep disorders
Insomnia Insomnia
Iron Circadian rhythm
Placebo Clinical medicine
Sleep Psychiatric diagnosis
Sleep Disturbance Clinical research
RTT
Health
Medicine
Inclusion criteria insomnia

Semantics

Type Source Name
disease MESH sleep onset latency
disease MESH sleep
drug DRUGBANK Methionine
drug DRUGBANK Iron
disease MESH Autism Spectrum Disorders
disease MESH Insomnia
drug DRUGBANK Sulfate ion

Original Article

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