Autism Spectrum DisorderPhase 2NCT01745497
Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
A Phase 2 study testing Ferrous sulfate in people with Autism Spectrum Disorder and Insomnia, run by University of Colorado, Denver at 4 sites in 2 countries.
Trial 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%). Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder, Insomnia
- What is being tested?
- Ferrous sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2012to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child has a clinical diagnosis of autism spectrum disorder, meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria, confirmed by the Autism Diagnostic Observation Schedule.
- Age 2 years to 10 years 11 months.
- Child has sleep onset latency of greater than 40 minutes on 3 or more nights per week, an average greater than 30 minutes per night, or night waking at least 3 times per week requiring parental intervention or lasting >20 minutes per night.
- A mean sleep latency of 30 minutes or more, or night waking will be need to be confirmed by 7 days of scorable actigraphy data prior to randomization.
- Ferritin between 17ng/ml and 49 ng/ml, confirmed at a central lab.
- The child has been screened for medical conditions that affect sleep by their clinician and referred for subspecialty evaluation, as needed, for coexisting disorders (e.g., Gastrointestinal reflux disease, epilepsy).
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- We will include children with coexisting medical, psychiatric, and neurological disorders as long as they have been evaluated by a physician and a treatment plan has been implemented, with the child on a stable dose of medication for one month
- Parents and their child are willing and able to provide informed consent (and assent, depending on child's age and cognitive function) and to cooperate with study procedures. Children with coexisting intellectual disability who can cooperate with study procedures are eligible.
- A child with known genetic syndromes comorbid with autism spectrum disorder (ASD), including Fragile X, down syndrome, neurofibromatosis, or tuberous sclerosis will be included as long as they meet other eligibility criteria.
Who cannot join
- Family history of hemochromatosis
- Elevated C-reactive protein (CRP) (may be repeated and enrolled once inflammation has resolved)
- Anemia - low hemoglobin (<11.0 g/dL for children <5 and <12.0 g/dL for children 6-11) (unless cause of anemia is known, is not due to iron deficiency, and there would be no contraindication to treatment with iron.)
- Fever in past week or active infection.
- Current treatment with iron in any amount other than that in a multivitamin
- Severe constipation/GI issues that are not adequately managed
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- Treatable sleep and medical condition such as obstructive sleep apnea or severe eczema that are not adequately managed.
- A child who is currently participating in other interventional research studies.
- Child with a seizure in the previous 2 years.
- A child taking medications that significantly influence RLS symptoms such as antinausea drugs (prochlorperazine, promethazine, triethylpyrazine or metoclopramide), antipsychotic drugs (haloperidol or phenothiazine derivatives such as chlorpromazine, promazine, triflupromazine, methotrimeprazine, fluphenazine, mesoridazine, perphenazine, thioridazine, and trifluoperazine), antidepressants that increase serotonin only if the onset of sleep issues was associated with starting the medication, and some cold and allergy medications-that contain sedating antihistamines(methdilazine, promethazine, trimeprazine).
- A child taking a medication that has a significant drug interaction with iron that cannot be addressed by the timing of administration such as Cholestyramine and Colestipol, Tagamet, Zantac, Pepcid, Axid, ACE inhibitors (captopril, enalapril, and lisinopril), carbidopa, levodopa, levothyroxine, tetracyclines, and quinolones.
- Girls who have started menstruating.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
- Allergic to turmeric (natural dye used in placebo).
- Allergy to prilocaine/lidocaine, if the participant requires it for procedures
- The onset of sleep symptoms was related to the onset of puberty.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Childrens Hospital Colorado
Aurora, Colorado, 80045
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Rochester
Rochester, New York, 14642
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Insomnia
- Being tested
- Ferrous sulfate, Placebo
- Keywords
- Autism Spectrum Disorder, Insomnia
- Medical subject headings
- Autism Spectrum Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Also called Fer-in-Sol
3mg/kg liquid
PlaceboDrug
Equivalent volume of liquid with similar color and taste.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous Sulfate | Experimental | 3mg/kg divided twice per day, 30 minutes before a meal or 2 hours after a meal Receives: Drug: Ferrous sulfate |
| Placebo | Placebo comparator | Equivalent volume of liquid placebo administered twice daily, before a meal or 2 hours after a meal Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in sleep onset
Improvement in sleep onset latency will be measured using actigraphy before and after treatment with iron vs placebo.
Measured: 3 month
Secondary outcomes (2)
Changes inDay time behavior
Daytime behavior will be assessed using parent questionnaires. Improvement in daytime behaviors such as attention will be assessed.
Measured: 3 months
Improvements in sleep maintenance insomnia
Improvement in sleep maintenance insomnia will be measured using actigraphy before and after treatment with iron vs placebo.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Treatment Network, Massachusetts General Hospital, The Emmes Company, LLC, Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Ann Reynolds, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745497
- Sponsor's protocol ID
- 12-0466
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2012
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richdale AL, Schreck KA. Sleep problems in autism spectrum disorders: prevalence, nature, & possible biopsychosocial aetiologies. Sleep Med Rev. 2009 Dec;13(6):403-11. doi: 10.1016/j.smrv.2009.02.003. Epub 2009 Apr 24.
PubMed 19398354Schreck KA, Mulick JA, Smith AF. Sleep problems as possible predictors of intensified symptoms of autism. Res Dev Disabil. 2004 Jan-Feb;25(1):57-66. doi: 10.1016/j.ridd.2003.04.007.
PubMed 14733976Picchietti D, Allen RP, Walters AS, Davidson JE, Myers A, Ferini-Strambi L. Restless legs syndrome: prevalence and impact in children and adolescents--the Peds REST study. Pediatrics. 2007 Aug;120(2):253-66. doi: 10.1542/peds.2006-2767.
PubMed 17671050Picchietti DL, Walters AS. Moderate to severe periodic limb movement disorder in childhood and adolescence. Sleep. 1999 May 1;22(3):297-300. doi: 10.1093/sleep/22.3.297.
PubMed 10341379Reed HE, McGrew SG, Artibee K, Surdkya K, Goldman SE, Frank K, Wang L, Malow BA. Parent-based sleep education workshops in autism. J Child Neurol. 2009 Aug;24(8):936-45. doi: 10.1177/0883073808331348. Epub 2009 Jun 1.
PubMed 19491110Bokkala S, Napalinga K, Pinninti N, Carvalho KS, Valencia I, Legido A, Kothare SV. Correlates of periodic limb movements of sleep in the pediatric population. Pediatr Neurol. 2008 Jul;39(1):33-9. doi: 10.1016/j.pediatrneurol.2008.03.008.
PubMed 18555170Picchietti MA, Picchietti DL. Advances in pediatric restless legs syndrome: Iron, genetics, diagnosis and treatment. Sleep Med. 2010 Aug;11(7):643-51. doi: 10.1016/j.sleep.2009.11.014.
PubMed 20620105Simakajornboon N, Kheirandish-Gozal L, Gozal D. Diagnosis and management of restless legs syndrome in children. Sleep Med Rev. 2009 Apr;13(2):149-56. doi: 10.1016/j.smrv.2008.12.002. Epub 2009 Jan 31.
PubMed 19186083Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
PubMed 17520797Latif A, Heinz P, Cook R. Iron deficiency in autism and Asperger syndrome. Autism. 2002 Mar;6(1):103-14. doi: 10.1177/1362361302006001008.
PubMed 11918106Herguner S, Kelesoglu FM, Tanidir C, Copur M. Ferritin and iron levels in children with autistic disorder. Eur J Pediatr. 2012 Jan;171(1):143-6. doi: 10.1007/s00431-011-1506-6. Epub 2011 Jun 4.
PubMed 21643649Dosman CF, Drmic IE, Brian JA, Senthilselvan A, Harford M, Smith R, Roberts SW. Ferritin as an indicator of suspected iron deficiency in children with autism spectrum disorder: prevalence of low serum ferritin concentration. Dev Med Child Neurol. 2006 Dec;48(12):1008-9. doi: 10.1017/S0012162206232225. No abstract available.
PubMed 17109795Dosman CF, Brian JA, Drmic IE, Senthilselvan A, Harford MM, Smith RW, Sharieff W, Zlotkin SH, Moldofsky H, Roberts SW. Children with autism: effect of iron supplementation on sleep and ferritin. Pediatr Neurol. 2007 Mar;36(3):152-8. doi: 10.1016/j.pediatrneurol.2006.11.004.
PubMed 17352947
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Treatment of Sleep Disorders in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01745497
- Acronym / sponsor ID
- 12-0466
- Conditions
- Autism Spectrum Disorder, Insomnia
- Keywords
- Autism Spectrum Disorder, Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Autism Treatment Network, Massachusetts General Hospital, The Emmes Company, LLC, Health Resources and Services Administration (HRSA)
- Study start
- Dec 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous Sulfate | Experimental | Drug: Ferrous sulfate3mg/kg divided twice per day, 30 minutes before a meal or 2 hours after a meal |
| Placebo | Placebo comparator | Drug: PlaceboEquivalent volume of liquid placebo administered twice daily, before a meal or 2 hours after a meal |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child has a clinical diagnosis of autism spectrum disorder, meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria, confirmed by the Autism Diagnostic Observation Schedule.
- Age 2 years to 10 years 11 months.
- Child has sleep onset latency of greater than 40 minutes on 3 or more nights per week, an average greater than 30 minutes per night, or night waking at least 3 times per week requiring parental intervention or lasting >20 minutes per night.
- A mean sleep latency of 30 minutes or more, or night waking will be need to be confirmed by 7 days of scorable actigraphy data prior to randomization.
- Ferritin between 17ng/ml and 49 ng/ml, confirmed at a central lab.
Key exclusion criteria (16 listed)
- Family history of hemochromatosis
- Elevated C-reactive protein (CRP) (may be repeated and enrolled once inflammation has resolved)
- Anemia - low hemoglobin (<11.0 g/dL for children <5 and <12.0 g/dL for children 6-11) (unless cause of anemia is known, is not due to iron deficiency, and there would be no contraindication to treatment with iron.)
- Fever in past week or active infection.
- Current treatment with iron in any amount other than that in a multivitamin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulfateAlso: Fer-in-Sol3mg/kg liquid | Drug | Ferrous Sulfate |
| PlaceboEquivalent volume of liquid with similar color and taste. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Changes inDay time behavior
Time frame: 3 months
Improvements in sleep maintenance insomnia
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Results publication: PubMed 19398354Richdale AL, Schreck KA. Sleep problems in autism spectrum disorders: prevalence, nature, & possible biopsychosocial aetiologies. Sleep Med Rev. 2009 Dec;13(6):403-11. doi: 10.1016/j.smrv.2009.02.003. Epub 2009 Apr 24.
- Results publication: PubMed 14733976Schreck KA, Mulick JA, Smith AF. Sleep problems as possible predictors of intensified symptoms of autism. Res Dev Disabil. 2004 Jan-Feb;25(1):57-66. doi: 10.1016/j.ridd.2003.04.007.
- Results publication: PubMed 17671050Picchietti D, Allen RP, Walters AS, Davidson JE, Myers A, Ferini-Strambi L. Restless legs syndrome: prevalence and impact in children and adolescents--the Peds REST study. Pediatrics. 2007 Aug;120(2):253-66. doi: 10.1542/peds.2006-2767.
- Results publication: PubMed 10341379Picchietti DL, Walters AS. Moderate to severe periodic limb movement disorder in childhood and adolescence. Sleep. 1999 May 1;22(3):297-300. doi: 10.1093/sleep/22.3.297.
- Results publication: PubMed 19491110Reed HE, McGrew SG, Artibee K, Surdkya K, Goldman SE, Frank K, Wang L, Malow BA. Parent-based sleep education workshops in autism. J Child Neurol. 2009 Aug;24(8):936-45. doi: 10.1177/0883073808331348. Epub 2009 Jun 1.
- Results publication: PubMed 18555170Bokkala S, Napalinga K, Pinninti N, Carvalho KS, Valencia I, Legido A, Kothare SV. Correlates of periodic limb movements of sleep in the pediatric population. Pediatr Neurol. 2008 Jul;39(1):33-9. doi: 10.1016/j.pediatrneurol.2008.03.008.
- Results publication: PubMed 20620105Picchietti MA, Picchietti DL. Advances in pediatric restless legs syndrome: Iron, genetics, diagnosis and treatment. Sleep Med. 2010 Aug;11(7):643-51. doi: 10.1016/j.sleep.2009.11.014.
- Results publication: PubMed 19186083Simakajornboon N, Kheirandish-Gozal L, Gozal D. Diagnosis and management of restless legs syndrome in children. Sleep Med Rev. 2009 Apr;13(2):149-56. doi: 10.1016/j.smrv.2008.12.002. Epub 2009 Jan 31.
- Results publication: PubMed 17520797Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
- Results publication: PubMed 11918106Latif A, Heinz P, Cook R. Iron deficiency in autism and Asperger syndrome. Autism. 2002 Mar;6(1):103-14. doi: 10.1177/1362361302006001008.
- Results publication: PubMed 21643649Herguner S, Kelesoglu FM, Tanidir C, Copur M. Ferritin and iron levels in children with autistic disorder. Eur J Pediatr. 2012 Jan;171(1):143-6. doi: 10.1007/s00431-011-1506-6. Epub 2011 Jun 4.
- Results publication: PubMed 17109795Dosman CF, Drmic IE, Brian JA, Senthilselvan A, Harford M, Smith R, Roberts SW. Ferritin as an indicator of suspected iron deficiency in children with autism spectrum disorder: prevalence of low serum ferritin concentration. Dev Med Child Neurol. 2006 Dec;48(12):1008-9. doi: 10.1017/S0012162206232225. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Reynolds, MD principal investigator
Children's Hospital Colorado
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferrous sulfate in people with Autism Spectrum Disorder and Insomnia, run by University of Colorado, Denver at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in sleep onset (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745497, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.