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

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ClinicalTrials.gov Identifier: NCT04078048
Recruitment Status : Completed
First Posted : September 4, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Saima Zahid, University of Health Sciences Lahore

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
Schizophrenia Dietary Supplement: Antioxidants (Vitamin C, E ) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 27, 2017
Actual Primary Completion Date : August 11, 2017
Actual Study Completion Date : November 15, 2017


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 Name: 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 Name: 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 Name: Tablet Vitamin E




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078048


Locations
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Pakistan
Saima Kouser
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
University of Health Sciences Lahore

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Responsible Party: Saima Zahid, Principal Investigator, University of Health Sciences Lahore
ClinicalTrials.gov Identifier: NCT04078048     History of Changes
Other Study ID Numbers: UHS
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: clinical trails registration

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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, University of Health Sciences Lahore:
Positive and Negative syndrome scale (PANSS)
Antioxidants
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamins
Ascorbic Acid
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Antioxidants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents