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

September 13, 2019 updated by: Saima Zahid, University of Health Sciences Lahore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Saima Kouser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C Group
Tablet Vitamin C 500 mg Once a day
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.
Other Names:
  • Tablet Vitamin E
Experimental: Vitamin E Group
Tablet Vitamin E 600 I U Twice daily
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.
Other Names:
  • Tablet Vitamin E
Placebo Comparator: Placebo Group
Capsule Paraffin oil 500 mg Once a day
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.
Other Names:
  • Tablet Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45-50 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2017

Primary Completion (Actual)

August 11, 2017

Study Completion (Actual)

November 15, 2017

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

clinical trails registration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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