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

NCT04078048 | Completed DMC

• 1 other identifier: UHS
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Positive and Negative syndrome scale (PANSS); Antioxidants; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale

  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

Study Arms (3)

Vitamin C Group

EXPERIMENTAL

Tablet Vitamin C 500 mg Once a day

Dietary Supplement: Antioxidants (Vitamin C, E )

Vitamin E Group

EXPERIMENTAL

Tablet Vitamin E 600 I U Twice daily

Dietary Supplement: Antioxidants (Vitamin C, E )

Placebo Group

PLACEBO COMPARATOR

Capsule Paraffin oil 500 mg Once a day

Dietary Supplement: Antioxidants (Vitamin C, E )

Interventions

Antioxidants (Vitamin C, E ) DIETARY_SUPPLEMENT

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.

Also known as: Tablet Vitamin E

Placebo Group; Vitamin C Group; Vitamin E Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All diagnosed schizophrenic patients 20-50 years of age
• visited department of psychiatry \& behavioral sciences King Edward medical university Lahore.

You may not qualify if:

• Patients diagnosed with axis i and axis ii disorders
• having any other pathological condition like hypertension, hyperlipidemia, and cardiac disorders.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Saima Kouser

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Antioxidants; Ascorbic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: April 27, 2017
• Primary Completion: August 11, 2017
• Study Completion: November 15, 2017
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)