Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
      Because polysomnography is not well tolerated in children with ASD and cannot measure sleep
      over time in a natural environment, improvements in sleep with treatment with iron will be
      measured by standard actigraphy (a watch that measures movements during sleep) and sleep
      diaries. The investigators also propose to evaluate periodic limb movement index (PLMI) as a
      predictor of response to iron treatment for insomnia in children with ASD, as measured by the
      PAM-RL, an actigraph designed to measure PLMS. The investigators will collect secondary data
      regarding attention and behavior over the course of the study to monitor improvement in
      daytime functioning in both groups. Many clinicians will empirically treat children with ASD,
      insomnia and low ferritin levels (< 50ng/ml) with iron. This is based on data from a previous
      open label trial demonstrating subjective improvement in restless sleep in children with ASD
      with low/low normal ferritin levels who were treated with iron. In order to evaluate the
      efficacy of such treatment, The investigators propose a randomized placebo-controlled trial
      of oral elemental iron for treatment of insomnia in children with ASD and ferritin levels
      that are low but above the laboratory cut off for deficiency. This study will evaluate the
      effectiveness of treatment of insomnia with oral ferrous sulfate (iron) at a dose of 3mg/kg
      divided twice per day for 3 months compared to placebo.
    

Intervention name(s): Ferrous sulfate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3mg/kg liquid; Equivalent volume of liquid with similar color and taste.
Other intervention name(s): Fer-in-Sol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Insomnia