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Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder

NCT06623227 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Placebo

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

DIETARY_SUPPLEMENT

Vitamin E and C

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

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Indonesia University

    collaborator OTHER

  • RSUP Dr. Wahidin Sudirohusodo

    collaborator OTHER

  • Rinvil Renaldi

    lead OTHER

Principal Investigators

  • Rinvil Renaldi, MD · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-28
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623227 on ClinicalTrials.gov