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

NCT07383363 | Completed

• 1 other identifier: Dr-Nadeem-Multan
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Reduction in severity

  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

Study Arms (2)

Vita 6 Group

EXPERIMENTAL

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

Zinc Group

EXPERIMENTAL

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

Interventions

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.

Vita 6 Group

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.

Zinc Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Children Hospital and Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Nadeem Iqbal

  Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  PRINCIPAL INVESTIGATOR

• Erum Afzal, FCPS

  Children's Hospital and institute of Child Health Multan, Punjab, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: September 23, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)