Clinical trial

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

Name
UKarachi2
Description
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.
Trial arms
Trial start
2021-01-01
Estimated PCD
2021-06-01
Trial end
2021-06-10
Status
Completed
Treatment
Risperidone
Antipsychotic Agent
Arms:
psychotic patients
Other names:
neuroleptics
Olanzapine
Antipsychotic Agent
Arms:
psychotic patients
Other names:
neuroleptics
Quetiapine
Antipsychotic Agent
Arms:
psychotic patients
Other names:
neuroleptics
Risperidone and Vitamin D and Vitamin E
vitamin
Arms:
psychotic patients
Other names:
vitamin
Olanzapine and Vitamin D and Vitamin E
vitamin and Antipsychotic agent
Arms:
psychotic patients
Other names:
vitamin
Quetiapine and Vitamin D and Vitamin E
Vitamin and Antipsychotic agents
Arms:
psychotic patients
Other names:
vitamin
Size
140
Primary endpoint
Glutathione Peroxidase
6months
Lipid Profile total cholesterol
6months
anti inflammatory markers gamma interferon
6months
Superoxide Dismutase Activity
6 months
lipid profile TG
6 months
lipid profile HDL
6 months
lipid profile VLDL
6 months
anti inflammatory markers TNF alpha
6 months
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 -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}
Updated at
2024-01-11

1 organization

3 products

1 drug

1 indication

Organization
Dr Rabia Arshad
Product
Quetiapine
Product
Olanzapine