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临床试验/NCT06200584
NCT06200584已完成不适用

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

Dr Rabia Arshad1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Glutathione Peroxidase

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

psychotic patients

Experimental

treatment given

干预措施: Risperidone (Drug)

psychotic patients

Experimental

treatment given

干预措施: Olanzapine (Drug)

psychotic patients

Experimental

treatment given

干预措施: Quetiapine (Drug)

psychotic patients

Experimental

treatment given

干预措施: Risperidone and Vitamin D and Vitamin E (Drug)

psychotic patients

Experimental

treatment given

干预措施: Olanzapine and Vitamin D and Vitamin E (Drug)

psychotic patients

Experimental

treatment given

干预措施: Quetiapine and Vitamin D and Vitamin E (Drug)

结局指标

主要结局

Glutathione Peroxidase

时间窗: 6months

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 cholesterol

时间窗: 6months

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

anti inflammatory markers gamma interferon

时间窗: 6months

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 Activity

时间窗: 6 months

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

lipid profile TG

时间窗: 6 months

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

lipid profile HDL

时间窗: 6 months

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

lipid profile VLDL

时间窗: 6 months

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

anti inflammatory markers TNF alpha

时间窗: 6 months

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

次要结局

  • Assessment of Psychiatric Improvement, Brief Psychiatric Rating Scale (BPRS)(6month)

研究者

发起方
Dr Rabia Arshad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Rabia Arshad

Professor

University of Karachi

研究点 (1)

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