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

NCT06200584 | Completed DMC

• 1 other identifier: UKarachi2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antipsychotics and Neuroleptics Toxicity

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)

  6month

Study Arms (2)

control

NO INTERVENTION

normal healthy individuals

psychotic patients

EXPERIMENTAL

treatment given

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

Interventions

Risperidone DRUG

Antipsychotic Agent

Also known as: neuroleptics

psychotic patients

Olanzapine DRUG

Antipsychotic Agent

Also known as: neuroleptics

psychotic patients

Quetiapine DRUG

Antipsychotic Agent

Also known as: neuroleptics

psychotic patients

Risperidone and Vitamin D and Vitamin E DRUG

vitamin

Also known as: vitamin

psychotic patients

Olanzapine and Vitamin D and Vitamin E DRUG

vitamin and Antipsychotic agent

Also known as: vitamin

psychotic patients

Quetiapine and Vitamin D and Vitamin E DRUG

Vitamin and Antipsychotic agents

Also known as: vitamin

psychotic patients

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients at mental hospitals are mostly women who are either pregnant or nursing.
• 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.
• Participants were also ruled out if they had preexisting conditions including renal or hepatic failure or a parathyroid disease

Sponsors & Collaborators

• Dr Rabia Arshad: lead

Study Sites (1)

Jinnah Post Graduate Medical Centre

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 22145446 BACKGROUND

• 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.

  PMID: 36368055 BACKGROUND

• 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.

  PMID: 27199286 BACKGROUND

• 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.

  PMID: 32428979 BACKGROUND

MeSH Terms

Interventions

Risperidone; Antipsychotic Agents; Olanzapine; Quetiapine Fumarate; Vitamin D; Vitamin E; Vitamins

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzopyrans; Pyrans; Micronutrients; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• DR MUHAMMAD ABID, MBBS

  BMSI, JINNAH POST GRADUATE MEDICAL CENTRE,Karachi,Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 10, 2021
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)