NCT07383363

Comparison of Efficacy and Safety of Vita 6 Versus Zinc Along With Applied Behavioural Therapy

Comparison of Efficacy and Safety of Vita 6 Versus Zinc Along With Applied Behavioural Therapy in Management of Autism Spectrum Disorder in Children Aged 3-14 Years

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The study seeks to fill the gaps in available local data regarding the diagnosis and its management, as multiple treatments are in practice. Therefore, the study aimed at the comparison of efficacy and safety of Vita 6 versus zinc along with applied behavioral therapy in the management of autism spectrum disorder in children aged 3-14 years.

Detailed description

Although autism spectrum disorder is a genetic disorder, environmental factors can play a role in its etiology. Local people and doctors now know about autism but have less knowledge about how to diagnose it and its management. Although its mainstay of treatment is applied behavioral therapy, a few medicines like Vita 6, zinc folinic acid, and methylcobalamin are now under trial in its management with favorable results. Since literature shows variable treatment outcomes for these medications, the findings would help clinicians to opt for a medication capable of reducing the severity of the symptoms with safety and economy.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Vita 6	Patients will be given one tablet of Vita 6 (50 mg) twice a day for 3 months, along with applied behavioral therapy.
DRUG	Zinc sulfate	Patients will receive syrup zinc sulfate 2 mg/kg/day as a single dose for 3 months, along with applied behavioral therapy.

Timeline

• Start date: 2025-09-23
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2026-02-03
• Last updated: 2026-04-15

Locations

1 site across 1 country: Pakistan