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NCT Number: NCT07383363

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital and Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vita 6

Drug

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

zinc sulfate

Drug

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

Primary outcomes

  1. Reduction in severity

    Time frame: 3 months

    Efficacy of the treatment will be assessed using the Childhood Autism Rating Scale (CARS) score, which ranges between 15 and 60. Efficacy will be deemed 'yes' if a CARS score lower than the baseline is achieved.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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