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Clinical Trials/NCT04078048
NCT04078048CompletedNot Applicable

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

University of Health Sciences Lahore1 site in 1 country105 target enrollmentStarted: April 27, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
1
Primary Endpoint
Positive and Negative Syndrome Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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:

Arms & Interventions

Vitamin C Group

Experimental

Tablet Vitamin C 500 mg Once a day

Intervention: Antioxidants (Vitamin C, E ) (Dietary Supplement)

Vitamin E Group

Experimental

Tablet Vitamin E 600 I U Twice daily

Intervention: Antioxidants (Vitamin C, E ) (Dietary Supplement)

Placebo Group

Placebo Comparator

Capsule Paraffin oil 500 mg Once a day

Intervention: Antioxidants (Vitamin C, E ) (Dietary Supplement)

Outcomes

Primary Outcomes

Positive and Negative Syndrome Scale

Time Frame: 45-50 minutes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saima Zahid

Principal Investigator

University of Health Sciences Lahore

Study Sites (1)

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