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Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder

NCT01745497 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-08-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ferrous sulfate

3mg/kg liquid

DRUG

Placebo

Equivalent volume of liquid with similar color and taste.

Sponsors & Collaborators

  • Autism Treatment Network

    collaborator NETWORK

  • Massachusetts General Hospital

    collaborator OTHER

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Ann Reynolds, MD · Childrens Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745497 on ClinicalTrials.gov