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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital and Institute of Child Health | Multan | Punjab Province | 66000 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019287 | Zinc Sulfate |
| ID | Term |
|---|---|
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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| 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. |
|
| D007287 |
| Inorganic Chemicals |
| D017967 | Zinc Compounds |