Role of Antioxidants (Vitamin C and E) in the Management of Schizophrenia

Schizophrenia Clinical Trial

Official title:

Role of Selected Antioxidants (Vitamin C and E) in the Management of Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078048
• Other study ID #: UHS
• Status: Completed
• Phase: N/A
• Start date: April 27, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: September 2019
• Source: University of Health Sciences Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 15, 2017
• Est. primary completion date: August 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• Antioxidants (Vitamin C, E )
For eight weeks, Vitamin C group was intervened with tablet vitamin c 500 mg once a day ,vitamin E group was intervened with Tablet vitamin E 600 I U twice a day.

Locations

Country	Name	City	State
Pakistan	Saima Kouser	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Health Sciences Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale	The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.	45-50 minutes