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

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Completed
CT.gov ID
NCT04078048
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
6.6
Actual Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Antioxidants (Vitamin C, E )
 N/A

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
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Selected Antioxidants (Vitamin C and E) in the Management of Schizophrenia
Actual Study Start Date :
Apr 27, 2017
Actual Primary Completion Date :
Aug 11, 2017
Actual Study Completion Date :
Nov 15, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Positive and Negative Syndrome Scale [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saima Kouser Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • University of Health Sciences Lahore

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saima Zahid, Principal Investigator, University of Health Sciences Lahore
    ClinicalTrials.gov Identifier:
    NCT04078048
    Other Study ID Numbers:
    • UHS
    First Posted:
    Sep 4, 2019
    Last Update Posted:
    Sep 17, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Saima Zahid, Principal Investigator, University of Health Sciences Lahore
    Positive and Negative syndrome scale (PANSS)
    Antioxidants
    Schizophrenia
    Additional relevant MeSH terms:
    Schizophrenia
    Vitamins
    Ascorbic Acid
    Vitamin E
    Antioxidants

    Study Results

    No Results Posted as of Sep 17, 2019