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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-10

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Antipsychotics and Neuroleptics Toxicity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control

normal healthy individuals

Group Type NO_INTERVENTION

No interventions assigned to this group

psychotic patients

treatment given

Group Type EXPERIMENTAL

Risperidone

Intervention Type DRUG

Antipsychotic Agent

Olanzapine

Intervention Type DRUG

Antipsychotic Agent

Quetiapine

Intervention Type DRUG

Antipsychotic Agent

Risperidone and Vitamin D and Vitamin E

Intervention Type DRUG

vitamin

Olanzapine and Vitamin D and Vitamin E

Intervention Type DRUG

vitamin and Antipsychotic agent

Quetiapine and Vitamin D and Vitamin E

Intervention Type DRUG

Vitamin and Antipsychotic agents

Interventions

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Risperidone

Antipsychotic Agent

Intervention Type DRUG

Olanzapine

Antipsychotic Agent

Intervention Type DRUG

Quetiapine

Antipsychotic Agent

Intervention Type DRUG

Risperidone and Vitamin D and Vitamin E

vitamin

Intervention Type DRUG

Olanzapine and Vitamin D and Vitamin E

vitamin and Antipsychotic agent

Intervention Type DRUG

Quetiapine and Vitamin D and Vitamin E

Vitamin and Antipsychotic agents

Intervention Type DRUG

Other Intervention Names

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neuroleptics neuroleptics neuroleptics vitamin vitamin vitamin

Eligibility Criteria

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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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Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No