Clinical trial NCT06200584: Synergistic Effect of Vitamin E & D in Reducing Risk of Effects Associated With Atypical Anti-psychotics
Official title: Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antipsychotics and Neuroleptics Toxicity
Lead sponsor: University of Karachi
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

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

Eligibility criteria: 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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Primary outcomes:
measure: Glutathione Peroxidase
timeFrame: 6months
measure: Lipid Profile total cholesterol
timeFrame: 6months
measure: anti inflammatory markers gamma interferon
timeFrame: 6months
measure: Superoxide Dismutase Activity
timeFrame: 6 months
measure: lipid profile TG
timeFrame: 6 months
measure: lipid profile HDL
timeFrame: 6 months
measure: lipid profile VLDL
timeFrame: 6 months
measure: anti inflammatory markers TNF alpha
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)
timeFrame: 6month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Post Graduate Medical Centre
state: Sindh
Study officials:
affiliation: BMSI, JINNAH POST GRADUATE MEDICAL CENTRE,Karachi,Pakistan
name: DR MUHAMMAD ABID, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.