At a glance
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Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
In Brief
A Phase 2 clinical trial evaluating Ferrous sulfate and Placebo for Autism Spectrum Disorder and Insomnia. Completed, enrolled 24 participants across 4 sites in 2 countries.
Detailed Summary
Autism Spectrum Disorders (ASD) are characterized by difficulties in language, social communication, and repetitive and restricted behaviors. ASD affects as many as 1 in 90-150 children. Sleep issues/insomnia is very common in children with ASD (50-80%). Insomnia has a negative impact on both the developmental and behavioral function of the child and the quality of life for the family. Causes of insomnia in children with ASD are multifactorial and can be difficult to treat effectively. Low iron stores, as manifest by low serum ferritin levels, is also common in children with ASD. Both insomnia and low iron stores are associated with Restless Legs Syndrome (RLS) and Periodic Limb Movement of Sleep (PLMS). Children with ASD often have difficulty communicating symptoms or tolerating Polysomnography (Sleep Study). This makes establishing a diagnosis of RLS or PLMS very difficult in children with ASD.
Study Details
Timeline
Interventions
3mg/kg liquid
Equivalent volume of liquid with similar color and taste.