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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07383363

Enrollment

Registered

2026-02-03

Start date

2025-09-23

Completion date

2026-03-30

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

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.

Interventions

DRUGVita 6

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

DRUGZinc sulfate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in severity	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.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORNadeem Iqbal

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

STUDY_DIRECTORErum Afzal, FCPS