Randomized, Placebo-Controlled Trial of Ferrous Sulfate to Treat Insomnia in Children With Autism Spectrum Disorders
| Autor: | Eric A. Macklin, Terry Katz, Beth A. Malow, Susan L. Hyman, Ann C. Halbower, Heidi V. Connolly, Shelly K. Weiss, Suzanne E. Goldman, Amy Shui, Ann Reynolds |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Sleep disorder business.industry Placebo-controlled study Actigraphy medicine.disease Placebo 03 medical and health sciences 0302 clinical medicine Developmental Neuroscience Neurology 030225 pediatrics Internal medicine Pediatrics Perinatology and Child Health medicine Insomnia Clinical Global Impression Neurology (clinical) Sleep onset latency medicine.symptom Sleep onset business 030217 neurology & neurosurgery |
| Zdroj: | Pediatric Neurology. 104:30-39 |
| ISSN: | 0887-8994 |
| DOI: | 10.1016/j.pediatrneurol.2019.07.015 |
| Popis: | Background Insomnia and low iron stores are common in children with autism spectrum disorders, and low iron stores have been associated with sleep disturbance. Methods 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. Results 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. Conclusion 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. |
| Databáze: | OpenAIRE |
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