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NCT01745497 · ClinicalTrials.gov registry record · Phase 2
Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01745497 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 24 participants.
The verdict
NCT01745497, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Ferrous sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01745497
The ClinicalTrials.gov registry entry for NCT01745497 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01745497 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01745497 about?
NCT01745497 is a clinical study titled "Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder". 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 de...
What is the current status of trial NCT01745497?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2012-12. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01745497?
The interventions under investigation include: Placebo (DRUG), Ferrous sulfate (DRUG).
Who is sponsoring clinical trial NCT01745497?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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