Related Experiment Video
Updated: Dec 31, 2025
Testing Sensory and Multisensory Function in Children with Autism Spectrum Disorder
Published on: April 22, 2015
Randomized, Placebo-Controlled Trial of Ferrous Sulfate to Treat Insomnia in Children With Autism Spectrum Disorders
Ann M Reynolds1, Heidi V Connolly2, Terry Katz1
1Department of Pediatrics, University of Colorado Denver, Aurora, Colorado.
Insights
Iron supplementation did not improve insomnia in children with autism spectrum disorder. While iron levels increased, key sleep measures and daytime behavior remained unchanged in this small trial.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Nutritional Science
Background:
- Insomnia and low iron stores are prevalent in children with autism spectrum disorder (ASD).
- Low iron stores are linked to sleep disturbances in children with ASD.
Purpose of the Study:
- To investigate the efficacy of oral ferrous sulfate in treating insomnia in children with autism spectrum disorder and low-normal ferritin levels.
- To assess the impact of iron supplementation on sleep parameters and daytime behavior.
Main Methods:
- A randomized, placebo-controlled trial was conducted with 20 children diagnosed with ASD and insomnia unresponsive to sleep education.
- Participants received either ferrous sulfate (3 mg/kg/day) or a placebo for three months.
- Sleep onset latency and wake time after sleep onset were measured using actigraphy.
Main Results:
- Iron supplementation effectively improved iron status compared to placebo (P=0.044).
- No significant improvements were observed in primary sleep outcomes, including sleep onset latency and wake time after sleep onset.
- A significant improvement was noted in the overall severity score of the Sleep Clinical Global Impression Scale (P=0.047).
Conclusions:
- Ferrous sulfate supplementation did not demonstrate significant improvement in primary insomnia measures in children with autism spectrum disorder.
- The trial's interpretation is limited due to low participant enrollment.
- Further research with larger cohorts may be warranted to explore the role of iron in ASD-related sleep disturbances.
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.
Related Concept Videos
01:19Autism Spectrum Disorder
These core symptoms manifest differently among individuals, ranging from mild to severe. The disorder's complexity extends beyond its clinical presentation, encompassing a diverse range of biological, cognitive, and sociocultural influences.
02:07Blind Procedures