Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ENROLLING BY INVITATION

NCT06623227

Effect of Increasing Total Antioxidant Capacity in Autism Spectrum Disorder

Sponsor: Rinvil Renaldi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-09-28

Completion Date

2025-06-30

Last Updated

2024-10-04

Healthy Volunteers

Conditions

Autism Spectrum Disorder

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

Inclusion Criteria: 1. 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. 2. Parents earn no less than IDR 3,434,298 (South Sulawesi Province Minimum Wage for 2024). 3. Subjects of both sexes, aged between 3-9 years old, may be included in the study. 4. The subject must meet DSM-5 criteria for a primary diagnosis of Autism. 5. 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. 6. 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. 7. Baseline Clinical Global Impression - Severity (CGI-S) score below 7. 8. 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. Exclusion Criteria: 1. Patients with organic disease and/or congenital malformation including known genetic syndromes for example, Rett syndrome, fragile-X syndrome, and Down Syndrome etc.). 2. 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. 3. Patients treated with anticoagulants. 4. Patients with serious medical illnesses (chronic renal disease, severe liver disease, cardiovascular disorders, malignant tumors, HIV infection). 5. Patients with a history of acute cerebrovascular episodes. 6. Patients with a history of stomach bleeding or active peptic ulcer. 7. Patients with documented allergy, hypersensitivity or intolerance to one of the excipients of the experimental or comparative product. 8. Patients have been consuming other antioxidants. 9. Patients with active urinary tract infections. 10. Patients with poor compliance and or no control back to the Hospital. Trial interruption criteria: 1. Patients whose medical conditions require starting treatment with anticoagulants. 2. Patients with severe medical conditions starting during the 3-month duration of the trial. 3. Patients who undergo a change in psychopharmacological or behavioral treatment during the 3-month duration of the trial.

Locations (1)

Doctoral Programme at Hasanuddin University

Makassar, South Sulawesi, Indonesia