Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623227
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Placebo-controlled Double-blind Study of Increasing Total Antioxidant Capacity with Vitamin E and C in Two Cohorts of Patients with Autism Spectrum Disorders
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACASD
Brief Summary:
This double-blind randomized controlled trial RCT has the aim to evaluating the effectiveness of increasing Total Antioxidant Capacity TAC as add-on intervention in two cohorts of patients with Autism Spectrum Disorder ASD who have received Risperidone 002-006 mgKgBW and Behavior Therapy as maintenance therapy Both groups will receive placebo pill or Vitamin E and C pill using randomization Clinical Symptoms Aberrant Behavior and Quality of Life in Children with ASD will be assessed after 12 weeks of treatment in this study Primary outcome measures of efficacy is Aberrant Behavior Checklist- Irritability ABC-Irritability and Secondary outcome measures include Childhood Autism Rating Scale CARS Clinical Global Impression Scale - Improvement CGI-I The PedsQL and The WHOQOL BREF
Detailed Description:
The continuation of ASD throughout life makes all efforts to optimize the abilities of children with ASD as early as possible so that their quality of life becomes better important Management to improve current symptoms and overcome aberrant behavior in children with ASD generally focuses on behavioral intervention psychotherapy and even pharmacotherapy but the results are not satisfactory because it takes time is expensive and unexpected side effects often occur after administering pharmacotherapy On the other hand research related to the role of oxidative stress has suggested a potential relationship between oxidative stress and autism pathophysiology that is not correlated with age and the underlying pathogenesis but damage caused by oxidative stress will exacerbate dysfunction in children with ASD through chronic inflammatory responses DNA and protein damage and mitochondrial superoxide production Oxidative stress will influence the clinical symptoms and pathogenesis of ASD Therefore efforts to control the balance of oxidative stress to improve symptoms and neuropsychological deficits in patients with ASD are important Lack of antioxidant capacity in children with ASD to neutralize and remove oxidants has been associated with the severity of clinical symptoms and aberrant behavior in children with ASD Therefore efforts to increase antioxidant capacity through providing antioxidants can offer a new strategy for dealing with accompanying symptoms in children with ASD
Vitamin E and Vitamin C are non-enzymatic antioxidants which function to strengthen the work of enzymatic antioxidants in the oxidant-elimination oxidation-reduction cycle process that occurs in the brain Its includes in group of antioxidants which also referred as chain breaking When used together with vitamin C which can function as a water-soluble antioxidant and other enzyme cofactors reduced vitamin C can directly regenerate vitamin E which simultaneously undergoes oxidation to become ascorbate Therefore the use of vitamin C will be more effective when used together with vitamin E Research has shown that administration with antioxidants such as vitamin E and vitamin C has a good effect on clinical symptoms and behavior in children with ASD
In this randomized controlled trial RCT patients with Autism Spectrum Disorder ASD who have received Risperidone and Behavior Therapy as maintenance therapy will be randomly assigned to receive either a placebo or a combination of Vitamins E 150-200 IU per day and C 100-200 mg per day for a duration of 3 months This study was designed to verify whether increasing the TAC using Vitamin E and C improves clinical symptoms aberrant behaviors and quality of life in children with ASD
This study shall include 50 patients with ASD aged 3-9 years old The study design of this RCT was balanced to all of patients treated with maintenance therapy as usual so that half of the patients will receive placebo and the remaining half will receive Vitamin E and C during 3 months The purpose is to observe whether the increase of TAC could improve the clinical symptoms aberrant behavior and quality of life in ASD patients In addition to clinical and psychometric parameters TAC will be measured at baseline after 6 weeks and 12 weeks by collecting 30-60 ml of fresh urine a general urinalysis examination to rule out acute urinary tract infections The TAC examination is carried out when the urine pH is normal and measurement with a calorimetric kit with enzyme method ABTS
Vitamin E and Vitamin C are non-enzymatic antioxidants which function to strengthen the work of enzymatic antioxidants in the oxidant-elimination oxidation-reduction cycle process that occurs in the brain Its includes in group of antioxidants which also referred as chain breaking When used together with vitamin C which can function as a water-soluble antioxidant and other enzyme cofactors reduced vitamin C can directly regenerate vitamin E which simultaneously undergoes oxidation to become ascorbate Therefore the use of vitamin C will be more effective when used together with vitamin E Research has shown that administration with antioxidants such as vitamin E and vitamin C has a good effect on clinical symptoms and behavior in children with ASD
In this randomized controlled trial RCT patients with Autism Spectrum Disorder ASD who have received Risperidone and Behavior Therapy as maintenance therapy will be randomly assigned to receive either a placebo or a combination of Vitamins E 150-200 IU per day and C 100-200 mg per day for a duration of 3 months This study was designed to verify whether increasing the TAC using Vitamin E and C improves clinical symptoms aberrant behaviors and quality of life in children with ASD
This study shall include 50 patients with ASD aged 3-9 years old The study design of this RCT was balanced to all of patients treated with maintenance therapy as usual so that half of the patients will receive placebo and the remaining half will receive Vitamin E and C during 3 months The purpose is to observe whether the increase of TAC could improve the clinical symptoms aberrant behavior and quality of life in ASD patients In addition to clinical and psychometric parameters TAC will be measured at baseline after 6 weeks and 12 weeks by collecting 30-60 ml of fresh urine a general urinalysis examination to rule out acute urinary tract infections The TAC examination is carried out when the urine pH is normal and measurement with a calorimetric kit with enzyme method ABTS
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