Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder

NCT06623227 | Enrolling By Invitation

• 1 other identifier: TAC_Study_ASD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 (0.02-0.06 mg/KgBW) 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.

Conditions

Autism Spectrum Disorder

Keywords

Total antioxidant capacity; Autism; Clinical symptoms; Aberrant behavior; Quality of life; Vitamin E; Vitamin C

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist - Irritability (ABC-I)

  An instrument which is used by parents to measure aberrant behavior in children which consists of 15 assessment items with a scale of 0-3 to assess the level of severity. Score between 0-45 with interpretation if score \<20, mild; 20-40 moderate; \>40, severe irritability.

  At 0, 6 and 12 weeks duration of trial

Secondary Outcomes (4)

• Childhood Autism Rating Scale (CARS)

  At 0, 6 and 12 weeks duration of trial

• Clinical Global Impression Scale- Improvement (CGI-I)

  At 0, 6 and 12 weeks duration of trial

• The Pediatric Quality of Life TM (The PedsQL)

  At 0, 6 and 12 weeks duration of trial

• WHOQOL-BREF

  At 0, 6 and 12 weeks duration of trial

Study Arms (2)

ASD Placebo

ACTIVE COMPARATOR

If the age is up to 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo. If age is above 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsule Placebo.

Dietary Supplement: Placebo

ASD Active compound

EXPERIMENTAL

If the age is up to 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 150 IU and Vitamin C 100 mg. If age is above 4 years old: • Risperidone (0.02-0.06 mg/KgBW) and Behavior Therapy as maintenance therapy and Capsul containing Vitamin E 200 IU and Vitamin C 200 mg.

Dietary Supplement: Vitamin E and C

Interventions

Placebo DIETARY_SUPPLEMENT

Capsule contains substances that are safe, non-active, and commonly used in pharmaceuticals (microcrystalline cellulose) with an appropriate coloring dye and in the active arms, Vitamin E and C. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules

ASD Placebo

Vitamin E and C DIETARY_SUPPLEMENT

Capsule Vitamin E (Natural Vitamin E, d-alpha tocopherol) 150 IU or 200 IU containing also Vitamin C 100 mg or 200 mg b.id depending on age. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules

ASD Active compound

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both parents or a legally authorized patient representative (LAR) must provide written informed consent. The parents and guardian must be able to understand and comply with the experimental protocol with a minimum of junior high school education.
• Parents earn no less than IDR 3,434,298 (South Sulawesi Province Minimum Wage for 2024).
• Subjects of both sexes, aged between 3-9 years old, may be included in the study.
• The subject must meet DSM-5 criteria for a primary diagnosis of Autism.
• Patients treated with Risperidone (0.02-0.06 mg/KgBW) are enrolled only if the treatment and dosage of these drugs has been constant for at least 2 months prior to enrollment in the trial and is kept constant throughout the 3-month duration of the trial.
• Patients undergoing any kind of behavioral intervention must have must have underwent the intervention at least 2 sessions prior to enrollment and the intervention must remain unchanged throughout the 3-month duration of the trial.
• Baseline Clinical Global Impression - Severity (CGI-S) score below 7.
• The patient is able to swallow the capsule or his/her parents are available to open it and administer immediately its content in a small quantity of juice or soft-drink.

You may not qualify if:

• Patients with organic disease and/or congenital malformation including known genetic syndromes for example, Rett syndrome, fragile-X syndrome, and Down Syndrome etc.).
• Patients with autism secondary to epileptic encephalopathy or with idiopathic autism co-morbid with seizures more frequent than one episode every 6 months despite ongoing anti epileptic drug therapy.
• Patients treated with anticoagulants.
• Patients with serious medical illnesses (chronic renal disease, severe liver disease, cardiovascular disorders, malignant tumors, HIV infection).
• Patients with a history of acute cerebrovascular episodes.
• Patients with a history of stomach bleeding or active peptic ulcer.
• Patients with documented allergy, hypersensitivity or intolerance to one of the excipients of the experimental or comparative product.
• Patients have been consuming other antioxidants.
• Patients with active urinary tract infections.
• Patients with poor compliance and or no control back to the Hospital.
• Trial interruption criteria:
• Patients whose medical conditions require starting treatment with anticoagulants.
• Patients with severe medical conditions starting during the 3-month duration of the trial.
• Patients who undergo a change in psychopharmacological or behavioral treatment during the 3-month duration of the trial.

Sponsors & Collaborators

• Rinvil Renaldi: lead
• University of Modena and Reggio Emilia: collaborator
• Indonesia University: collaborator
• RSUP Dr. Wahidin Sudirohusodo: collaborator

Study Sites (1)

Doctoral Programme at Hasanuddin University

Makassar, South Sulawesi, Indonesia

Location

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MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Rinvil Renaldi, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, all care providers, investigators and outcome assessors are blind to treatment status, as well as patients and family. Three investigators, who have no direct contact with patients and families, are responsible for managing the study procedures or treatments. Another investigator, who is not involved in assessing the outcomes, interacts with families to answer any questions regarding the trial or medical issues. This investigator also ensures that the outcome assessors are not influenced by any contact with families between the assessment periods (0, 6, and 12 weeks). Families are asked to refrain from discussing their experiences and the trial outcomes on social media.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Child and Adolescent Psychiatrist

Model Details: Each patients treated with Risperidone and Behavior Therapy as maintanence therapy will divided into a controled group which receive plasebo and the other as intervention group which received Vitamin E (150-200 IU/d) and C (100-200 mg/d) for 3 months. Patients are assessed at T0, T6 and T12 wk. Administration of active compound and placebo is in double-blind.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: September 28, 2024
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)