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

Muhammad Aamir Latif

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Drug: Vita 6; Drug: Zinc sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT07383363

Dr-Nadeem-Multan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children of any gender
• Aged 3-12 years
• Newly diagnosed patients of autism spectrum disorder following the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
• Not taking any treatment

Exclusion criteria

• With any of psychiatric disorder
• With any of movement disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Vita 6 Group

Experimental group

Description:

Patients will be given one tablet of Vita 6 (50 mg) twice a day for 3 months, along with applied behavioral therapy.

Treatment:

Drug: Vita 6

Zinc Group

Experimental group

Description:

Patients will receive syrup zinc sulfate 2 mg/kg/day as a single dose for 3 months, along with applied behavioral therapy.

Treatment:

Drug: Zinc sulfate