drugset / Trial / NCT01745497

Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder

NCT01745497

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2012-12
Primary completion
2015-08
Completion
2015-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferrous Sulfate Diagnostic / imaging agent 3 mg/kg Oral