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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Dietary Supplement: Antioxidants (Vitamin C, E )

• Registration Number: NCT04078048
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-04-27
• Primary Completion: 2017-08-11
• Study Completion: 2017-11-15
• Status Verified: 2019-09
• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-04
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin E Group	Antioxidants (Vitamin C, E )	Tablet Vitamin E 600 I U Twice daily
Placebo Group	Antioxidants (Vitamin C, E )	Capsule Paraffin oil 500 mg Once a day
Vitamin C Group	Antioxidants (Vitamin C, E )	Tablet Vitamin C 500 mg Once a day

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Saima Kouser; 🇵🇰 Lahore, Punjab, Pakistan