Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics

Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics

Atypical antipsychotic drugs are commonly used to treat psychiatric illnesses but they are significantly associated with side effects including acute dystonia, akathisia, parkinsonism (rigidity and tremor), tardive dyskinesia, bradycardia, hypotension, impotence, sleepiness, seizures, severe dreams or nightmares, and hyperprolactinaemia. Vitamin D and E, have been the focus of much research in the past fifteen years, which has revealed multiple roles in the development and function of the body. According to mounting data from the domains of epidemiology and neuroscience, vitamin D and E deficiency have been related to a number of neuropsychiatric issues as well as neurodegenerative diseases. Additionally, antioxidants like vitamin E help to prevent inflammation and highly reactive oxygen molecules from damaging normal cells. The use of vitamin E and D supplements has been suggested to improve the overall outcomes of psychiatric illnesses and neurological diseases. However, the synergistic effect of vitamins E and D in reducing the risk of the adverse effects associated with atypical antipsychotics and improvement in psychiatric illness is not well understood. Therefore, this study was designed to investigate the potential synergistic effect of vitamin E and D supplements for reducing the adverse effects associated with atypical antipsychotics.

Study Overview

• Status: Completed
• Conditions: Antipsychotics and Neuroleptics Toxicity
• Intervention / Treatment: Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Risperidone and Vitamin D and Vitamin E; Drug: Olanzapine and Vitamin D and Vitamin E; Drug: Quetiapine and Vitamin D and Vitamin E

Detailed Description

Inclusion Criteria:

1. Patients using antipsychotic medications such as quetiapine, olanzapine, or risperidone 3. Participants who are between the ages of 20 - 70 years 3. Both gender patients male and female 4. Patients with no other chronic morbidity

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Jinnah Post graduate Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Those using antipsychotic medications such as quetiapine, olanzapine, or risperidone.
2. Participants who are between the ages of 20 - 70 years are both sex male and female
3. participants who are taking a combination of one or two antipsychotics.
4. Participants who were under antipsychotic therapy and not diagnosed with type 2 diabetes mellitus.

Exclusion Criteria:

1. Patients at mental hospitals are mostly women who are either pregnant or nursing.
2. Patients who were taking anticonvulsants, ketoconazole, or corticosteroids, or who had a history of other mental or neurologic illnesses, as well as those who used phosphor, calcium, vitamin D supplements or teriparatide, were not included in the study.

3. Participants were also ruled out if they had preexisting conditions including renal or hepatic failure or a parathyroid disease

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; normal healthy individuals
Experimental: psychotic patients; treatment given	Drug: Risperidone; Antipsychotic Agent; Other Names: neuroleptics; Drug: Olanzapine; Antipsychotic Agent; Other Names: neuroleptics; Drug: Quetiapine; Antipsychotic Agent; Other Names: neuroleptics; Drug: Risperidone and Vitamin D and Vitamin E; vitamin; Other Names: vitamin; Drug: Olanzapine and Vitamin D and Vitamin E; vitamin and Antipsychotic agent; Other Names: vitamin; Drug: Quetiapine and Vitamin D and Vitamin E; Vitamin and Antipsychotic agents; Other Names: vitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glutathione Peroxidase	Serum levels of Glutathione Peroxidase would be determined in each group using a colorimetric approach and commercially available kits because both enzymes are commonly involved in the response to oxidative stress in tissue.(GPX ELISA kit )	6months
Lipid Profile total cholesterol	The lipid profile includes the measurement of total cholesterol level in the blood	6months
anti inflammatory markers gamma interferon	Expression levels of interferon gamma are determined by polymerase chain reaction. Primers specific to TNF- and IFN- were designed and synthesized for use in polymerase chain reaction (PCR) copy synthesis.	6months
Superoxide Dismutase Activity	Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits	6 months
lipid profile TG	The lipid profile includes the measurement of triglycerides level in the blood	6 months
lipid profile HDL	The lipid profile includes the measurement of high density lipoproteins in the blood	6 months
lipid profile VLDL	The lipid profile includes the measurement of very low density lipoprotein levels level in the blood	6 months
anti inflammatory markers TNF alpha	Tumor necrosis factor alpha expression is determined by polymerase chain reaction.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)	The Brief Mental Rating Scale (BPRS) is a frequently used measure in psychiatry for assessing the severity of various mental symptoms. It is intended to assess the psychological and behavioral features of those suffering from mental health issues. The BPRS is made up of 18 components, each reflecting a different symptom domain. maximum score 168 and minimum score 24	6month

Collaborators and Investigators

• Sponsor: Dr Rabia Arshad
• Investigators: Principal Investigator: DR MUHAMMAD ABID, MBBS, BMSI, JINNAH POST GRADUATE MEDICAL CENTRE,Karachi,Pakistan

Publications and helpful links

General Publications

• Nwosu BU, Meltzer B, Maranda L, Ciccarelli C, Reynolds D, Curtis L, King J, Frazier JA, Lee MM. A potential role for adjunctive vitamin D therapy in the management of weight gain and metabolic side effects of second-generation antipsychotics. J Pediatr Endocrinol Metab. 2011;24(9-10):619-26. doi: 10.1515/jpem.2011.300.
• de Bartolomeis A, Ciccarelli M, Vellucci L, Fornaro M, Iasevoli F, Barone A. Update on novel antipsychotics and pharmacological strategies for treatment-resistant schizophrenia. Expert Opin Pharmacother. 2022 Dec;23(18):2035-2052. doi: 10.1080/14656566.2022.2145884. Epub 2022 Nov 17.
• Nagashima T, Shirakawa H, Nakagawa T, Kaneko S. Prevention of antipsychotic-induced hyperglycaemia by vitamin D: a data mining prediction followed by experimental exploration of the molecular mechanism. Sci Rep. 2016 May 20;6:26375. doi: 10.1038/srep26375.
• Yuan T, Wang S, Le J, Li Y. Effects of Atypical Antipsychotics on Neuroactive Vitamins in Patients With Schizophrenia. J Clin Pharmacol. 2020 Oct;60(10):1355-1361. doi: 10.1002/jcph.1625. Epub 2020 May 19.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 10, 2021

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Protective Agents; Micronutrients; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antioxidants; Selective Serotonin Reuptake Inhibitors; Olanzapine; Vitamin D; Cholecalciferol; Vitamin E; Tocopherols; alpha-Tocopherol; Quetiapine Fumarate; Vitamins; Risperidone; Tocotrienols; Ergocalciferols; Antipsychotic Agents
• Other Study ID Numbers: UKarachi2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No