Synergistic Effect of Vitamin E & D in Reducing the Risk of Effects Associated With Atypical Antipsychotics
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:
- 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
- 否
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
treatment given
干预措施: Risperidone (Drug)
psychotic patients
treatment given
干预措施: Olanzapine (Drug)
psychotic patients
treatment given
干预措施: Quetiapine (Drug)
psychotic patients
treatment given
干预措施: Risperidone and Vitamin D and Vitamin E (Drug)
psychotic patients
treatment given
干预措施: Olanzapine and Vitamin D and Vitamin E (Drug)
psychotic patients
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
Dr Rabia Arshad
Professor
University of Karachi
