Ignite Creation Date:
2024-05-06 @ 1:35 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01847521
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2013-05-01
Brief Title:
Effects of the Anti-inflammatory Flavonoid Luteolin on Behavior in Children With Autism Spectrum Disorders
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Increasing evidence indicates that brain inflammation is important in the pathogenesis of neuropsychiatric disorders including at least a significant proportion of subjects with Autism spectrum disorder ASD Natural flavonoids such as luteolin and quercetin exhibit potent antioxidant and anti-inflammatory activities inhibit the release of inflammatory mediators from human mast cells and reduce maternal interleukin 6-induced autism-like behavioral deficits related to social interactions in mice In a case series of 37 children with ASD who took a dietary supplement containing luteolin and quercetin for 4 months reported gains in eye contact attention and social interaction according to parental reports
Aim The purpose of this study was to assess the effectiveness and tolerability in white children with ASD of a dietary supplement containing 2 flavonoids luteolin and quercetin and the quercetin glycoside rutin
Methods Fifty children 42 boys and 8 girls divided into 2 equal age groups 4-6 years old and 7-10 years with ASD were enrolled in a 26-week prospective open-label trial at the 2nd University Department of Psychiatry at Attikon General Hospital Athens Greece the Ethics Committee of which approved the study The parents of all subjects were informed of the studys aims including risks versus benefits of participating and not participating as well as the inclusion and exclusion criteria and they written consent for participation in the study
Participants had already been diagnosed with ASD based on clinical assessments and this diagnosis was corroborated at the Attikon clinic by meeting the cutoff scores on both the DSM-IV-TR symptom list and the ADOS algorithm All children were medication naive Apart from the diagnostic evaluation the assessment also included a thorough medical evaluation comprising a physical examination and health history including a review of allergic and gastrointestinal symptoms as well as any food allergies or food intolerance All concurrent interventions were thoroughly noted type and hours and the same was done at all visits After meeting screening criteria subjects were evaluated at the baseline visit mid-trial visit at 18 weeks and final visit at 26 weeks
Children were administered a dietary formulation containing 2 flavonoids luteolin 100 mgcapsule and quercetin 70 mgcapsule and the quercetin glycoside rutin 30 mgcapsule The dose used was 1 softgel capsule per 10 kg 22 lb weight per day with food for 26 weeks
The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive Behavior Scales VABS communication daily living skills and socialization The VABS was chosen because the impact of an agent on adaptive functioning in real life is even more important for obtaining a better quality of life than just alleviation of some symptoms The raw scores from the interview can be also expressed as an age-equivalent score and a standard score compared with those of the subjects peers There are also supplementary special norms for individuals with autism Although standard scores could be more useful in subject characterization their use as an outcome measure has been proven to be less sensitive due to floor effects and reduced variability especially in short time periods and thus these scores underestimate change Conversely scores of special norms tend to overestimate change as a small increase in a raw score can produce a big improvement in special norm percentile rank Thus raw scores and age-equivalent scores seem to be the most appropriate for use as outcome measures with the latter being more easily interpreted as change over time
Secondary outcomes included the Aberrant Behavior Checklist ABC the Autism Treatment Evaluation Checklist ATEC and the Clinical Global Impression-Improvement score CGI-I To explore other possible effects of the formulation not captured from the aforementioned instruments we chose to record any other benefits observed and reported by the parents during its use For this the primary clinician KF conducted telephone or in-person interviews of the parents independently of the assessing clinician AT to discuss the possible gains of the child CGI-I was also independently coded by the primary clinician with personal assessments as well as with information gathered by parents and in the majority of cases by the subjects trainers
Compliance was monitored by softgel capsule count and the parents assurance that the capsules had actually been taken at each visit in case of a capsule count 85 of the prescribed dosage at midterm and at the end of the study the subject was excluded from the final analysis
Adverse events were systematically recorded on an adverse event form by using scales indicating severity relationship to the study procedures action taken and any therapy required
Aim The purpose of this study was to assess the effectiveness and tolerability in white children with ASD of a dietary supplement containing 2 flavonoids luteolin and quercetin and the quercetin glycoside rutin
Methods Fifty children 42 boys and 8 girls divided into 2 equal age groups 4-6 years old and 7-10 years with ASD were enrolled in a 26-week prospective open-label trial at the 2nd University Department of Psychiatry at Attikon General Hospital Athens Greece the Ethics Committee of which approved the study The parents of all subjects were informed of the studys aims including risks versus benefits of participating and not participating as well as the inclusion and exclusion criteria and they written consent for participation in the study
Participants had already been diagnosed with ASD based on clinical assessments and this diagnosis was corroborated at the Attikon clinic by meeting the cutoff scores on both the DSM-IV-TR symptom list and the ADOS algorithm All children were medication naive Apart from the diagnostic evaluation the assessment also included a thorough medical evaluation comprising a physical examination and health history including a review of allergic and gastrointestinal symptoms as well as any food allergies or food intolerance All concurrent interventions were thoroughly noted type and hours and the same was done at all visits After meeting screening criteria subjects were evaluated at the baseline visit mid-trial visit at 18 weeks and final visit at 26 weeks
Children were administered a dietary formulation containing 2 flavonoids luteolin 100 mgcapsule and quercetin 70 mgcapsule and the quercetin glycoside rutin 30 mgcapsule The dose used was 1 softgel capsule per 10 kg 22 lb weight per day with food for 26 weeks
The primary outcomes were the age-equivalent scores in the 3 domains of the Vineland Adaptive Behavior Scales VABS communication daily living skills and socialization The VABS was chosen because the impact of an agent on adaptive functioning in real life is even more important for obtaining a better quality of life than just alleviation of some symptoms The raw scores from the interview can be also expressed as an age-equivalent score and a standard score compared with those of the subjects peers There are also supplementary special norms for individuals with autism Although standard scores could be more useful in subject characterization their use as an outcome measure has been proven to be less sensitive due to floor effects and reduced variability especially in short time periods and thus these scores underestimate change Conversely scores of special norms tend to overestimate change as a small increase in a raw score can produce a big improvement in special norm percentile rank Thus raw scores and age-equivalent scores seem to be the most appropriate for use as outcome measures with the latter being more easily interpreted as change over time
Secondary outcomes included the Aberrant Behavior Checklist ABC the Autism Treatment Evaluation Checklist ATEC and the Clinical Global Impression-Improvement score CGI-I To explore other possible effects of the formulation not captured from the aforementioned instruments we chose to record any other benefits observed and reported by the parents during its use For this the primary clinician KF conducted telephone or in-person interviews of the parents independently of the assessing clinician AT to discuss the possible gains of the child CGI-I was also independently coded by the primary clinician with personal assessments as well as with information gathered by parents and in the majority of cases by the subjects trainers
Compliance was monitored by softgel capsule count and the parents assurance that the capsules had actually been taken at each visit in case of a capsule count 85 of the prescribed dosage at midterm and at the end of the study the subject was excluded from the final analysis
Adverse events were systematically recorded on an adverse event form by using scales indicating severity relationship to the study procedures action taken and any therapy required
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None