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

April 14, 2026 updated by: Muhammad Aamir Latif

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 66000
        • Children Hospital and Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vita 6 Group
Patients will be given one tablet of Vita 6 (50 mg) twice a day for 3 months, along with applied behavioral therapy.
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.
Experimental: Zinc Group
Patients will receive syrup zinc sulfate 2 mg/kg/day as a single dose 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Nadeem Iqbal, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan
  • Study Director: Erum Afzal, FCPS, Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2025

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr-Nadeem-Multan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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