Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01745497|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Insomnia||Drug: Ferrous sulfate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Ferrous Sulfate
3mg/kg divided twice per day, 30 minutes before a meal or 2 hours after a meal
Drug: Ferrous sulfate
Other Name: Fer-in-Sol
Placebo Comparator: Placebo
Equivalent volume of liquid placebo administered twice daily, before a meal or 2 hours after a meal
Equivalent volume of liquid with similar color and taste.
- Improvement in sleep onset [ Time Frame: 3 month ]Improvement in sleep onset latency will be measured using actigraphy before and after treatment with iron vs placebo.
- Changes inDay time behavior [ Time Frame: 3 months ]Daytime behavior will be assessed using parent questionnaires. Improvement in daytime behaviors such as attention will be assessed.
- Improvements in sleep maintenance insomnia [ Time Frame: 3 months ]Improvement in sleep maintenance insomnia will be measured using actigraphy before and after treatment with iron vs placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745497
|United States, Colorado|
|Childrens Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||Ann Reynolds, MD||Childrens Hospital Colorado|