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临床试验/CTRI/2025/11/096868
CTRI/2025/11/096868尚未招募不适用

The Effect of vitamin D supplementation on clinical ,electroencephalographic and metabolic outcomes in schizophrenia patients under clozapine treatment :A Hospital based controlled study

Central Institute of Psychiatry, Ranchi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Changes in symptomatology, metabolic parameters (lipid profile, glucose metabolism), and low-frequency electroencephalographic activities (delta and theta power) in patients with schizophrenia on Clozapine therapy receiving weekly vitamin D supplementation (60,000 IU)

研究概览

简要总结

Title: The Effect of Vitamin D Supplementation on Clinical, Electroencephalographic, and Metabolic

Outcomes in Schizophrenia Patients Under Clozapine Treatment: A Hospital-Based Controlled Study

Researcher: Dr. Bipin Kumar Yadav Guide: Dr. Umesh S. Institution: Central Institute of Psychiatry, Ranchi, Jharkhand

Background: Schizophrenia is a chronic psychiatric disorder marked by significant cognitive and functional impairments. Clozapine remains the gold standard for treatment-resistant schizophrenia but is associated with persistent symptoms and adverse metabolic effects. Recent evidence indicates that vitamin D deficiency is prevalent among schizophrenia patients and may contribute to poor cognitive, metabolic, and neurophysiological outcomes.

Rationale: Vitamin D plays a crucial neuroprotective role by regulating NMDA receptor activity and reducing pro-inflammatory cytokines. Its deficiency may exacerbate cognitive impairment, metabolic dysfunction, and seizure susceptibility in patients on clozapine. However, there is limited research evaluating vitamin D supplementation as an adjunctive therapy in this population.

Aim: To assess the impact of weekly vitamin D supplementation (60,000 IU) on clinical, metabolic, and EEG parameters in schizophrenia patients with vitamin D deficiency receiving clozapine therapy.

Objectives: 1. Evaluate improvement in psychotic symptoms (PANSS, CGI-S). 2. Assess changes in cognitive function (MoCA). 3. Examine metabolic indices (BMI, RBS, lipid profile). 4. Analyze EEG delta and theta power alterations. 5. Compare results between vitamin D–deficient and vitamin D–sufficient groups.

Methodology: A 4-week, hospital-based, prospective controlled study involving 40 schizophrenia inpatients (20 vitamin D deficient receiving supplementation; 20 with normal levels). Baseline and follow-up assessments were conducted using standardized rating scales, metabolic tests, and qEEG analysis. Data will be analyzed using SPSS v29 with appropriate statistical tests.

Expected Outcomes: Vitamin D supplementation is anticipated to improve clinical symptoms, enhance cognitive performance, normalize EEG activity, and reduce metabolic disturbances in clozapine-treated patients.

Significance: This study may highlight vitamin D’s potential as an effective, low-cost adjunctive therapy to improve neuropsychiatric and metabolic outcomes in treatment-resistant schizophrenia.


Abstract: Schizophrenia is a chronic disorder characterized by cognitive and functional decline. Clozapine, although the most effective antipsychotic for treatment-resistant schizophrenia, is often associated with persistent symptoms and metabolic side effects. Emerging evidence suggests that vitamin D deficiency is common in schizophrenia and may contribute to neurocognitive and metabolic disturbances. This hospital-based, prospective controlled study aims to evaluate the effect of weekly vitamin D supplementation (60,000 IU) on clinical, metabolic, and electroencephalographic (EEG) outcomes in vitamin D–deficient schizophrenia patients on clozapine. Forty inpatients will be enrolled and divided into two groups—vitamin D–deficient patients receiving supplementation and those with normal levels. Clinical outcomes (PANSS, CGI-S), cognitive function (MoCA), metabolic parameters (BMI, RBS, lipid profile), and EEG measures (delta and theta power) will be assessed over four weeks. Data will be analyzed using SPSS. It is hypothesized that vitamin D supplementation will result in improved clinical and metabolic outcomes and favorable EEG changes. The findings may provide evidence supporting vitamin D as an adjunctive treatment in schizophrenia patients maintained on clozapine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient with diagnosis of Schizophrenia in ICD
  • Illness duration of atleast 2 years 3.

排除标准

  • Any other comorbid psychiatric diagnosis
  • Any comorbid substance use
  • Significant current or past medical illness
  • Known hypersensitivity to Vitamin D.

结局指标

主要结局

Changes in symptomatology, metabolic parameters (lipid profile, glucose metabolism), and low-frequency electroencephalographic activities (delta and theta power) in patients with schizophrenia on Clozapine therapy receiving weekly vitamin D supplementation (60,000 IU)

时间窗: 0, 2nd and 4th week

次要结局

未报告次要终点

研究者

发起方
Central Institute of Psychiatry, Ranchi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Bipin Kumar Yadav

Central Institute of Psychiatry, Ranchi

研究点 (1)

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