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

Registration Number
NCT06200584
Lead Sponsor
Dr Rabia Arshad
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, hav...

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
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.
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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 & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
psychotic patientsRisperidone and Vitamin D and Vitamin Etreatment given
psychotic patientsOlanzapine and Vitamin D and Vitamin Etreatment given
psychotic patientsQuetiapine and Vitamin D and Vitamin Etreatment given
psychotic patientsOlanzapinetreatment given
psychotic patientsQuetiapinetreatment given
psychotic patientsRisperidonetreatment given
Primary Outcome Measures
NameTimeMethod
Glutathione Peroxidase6months

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 )

Lipid Profile total cholesterol6months

The lipid profile includes the measurement of total cholesterol level in the blood

anti inflammatory markers gamma interferon6months

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.

Superoxide Dismutase Activity6 months

Superoxide Dismutase were determined in each group using a colorimetric approach and commercially available kits

lipid profile TG6 months

The lipid profile includes the measurement of triglycerides level in the blood

lipid profile HDL6 months

The lipid profile includes the measurement of high density lipoproteins in the blood

lipid profile VLDL6 months

The lipid profile includes the measurement of very low density lipoprotein levels level in the blood

anti inflammatory markers TNF alpha6 months

Tumor necrosis factor alpha expression is determined by polymerase chain reaction.

Secondary Outcome Measures
NameTimeMethod
Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)6month

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 ...

Trial Locations

Locations (1)

Jinnah Post Graduate Medical Centre

🇵🇰

Karachi, Sindh, Pakistan

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