Clinical trial NCT04078048: Role of Antioxidants (Vitamin C and E) in the Management of Schizophrenia
Official title: Role of Selected Antioxidants (Vitamin C and E) in the Management of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Positive and Negative syndrome scale (PANSS)
Antioxidants
Schizophrenia
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: Antioxidants are substances that are considered as a defensive material which protects cells from destruction. It is evident that use of food stuff rich in antioxidant will fortify one's ability to encounter with physical \& mental disorders. Since, among several potential elucidations, oxidative stress is more likely deliberated as one of the causative factors which give rise to cognitive and functional impairment. This deterioration further result in intricacy in ones thought process as progressive brain changes crop-up schizophrenic unfold. Therefore, this study was conducted with objectives to explore the role of selected antioxidants (vitamin C \& E) and to compare the role of both vitamins as an add-on management of schizophrenia .Materials \& Methods: One hundred and five patients were selected from department of psychiatry King Edward Medical University Lahore, and assigned into 3 groups by simple random lottery method. For eight weeks, Vitamin C group intervened with 500mg vitamin C tablet once a day, vitamin E group with 600IU vitamin E twice daily and placebo group was given 500 mg paraffin oil capsule daily. PANSS scale was used to assess the symptoms of schizophrenia. Demographic information was collected by structured questionnaire. Dietary habits were assessed by food frequency questionnaire.

Detailed description: Background: Antioxidants such as Vitamin C and E are substances that are considered as a defensive material which protects cells from destruction. It is evident that use of food stuff rich in antioxidant will fortify one's ability to encounter with physical \& mental disorders. Since, among several potential elucidations, oxidation stress is more likely deliberated as one of the causative factors which give rise to cognitive and functional impairment. Therefore, this study was conducted with objectives to explore the role of selected antioxidants (vitamin C \& E) and to compare the role of both vitamins as an add-on management of schizophrenia .Materials \& Methods: One hundred and five patients were selected from department of psychiatry King Edward Medical University Lahore, and assigned into 3 groups by simple random lottery method. For the period of two months, Vitamin C group intervened with 500 mg vitamin C tablet once a day, vitamin E group with 600 I U vitamin E twice daily and placebo group was given 500 mg paraffin oil capsule daily. PANSS (Positive and Negative Symptoms Scale) was used to assess the symptoms of schizophrenia. Demographic information was collected by structured questionnaire. Dietary habits were assessed by (FFQ) food frequency questionnaire.

Eligibility criteria: Inclusion Criteria:

* INCLUSION CRITERIA:

  * All diagnosed schizophrenic patients 20-50 years of age
  * visited department of psychiatry \& behavioral sciences King Edward medical university Lahore.
* EXCLUSION CRITERIA:

  * Patients diagnosed with axis i and axis ii disorders
  * having any other pathological condition like hypertension, hyperlipidemia, and cardiac disorders.

Exclusion Criteria:

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Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: 45-50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Saima Kouser
state: Punjab
Study officials:
References: