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CTRI Number  CTRI/2025/11/096868 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Vitamin D supplementation in patients with schizophrenia 
Scientific Title of Study   The Effect of vitamin D supplementation on clinical ,electroencephalographic and metabolic outcomes in schizophrenia patients under clozapine treatment :A Hospital based controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bipin Kumar Yadav 
Designation  Junior Resident 
Affiliation  Central Institute of Psychiatry, Ranchi 
Address  CIP Ranchi, Kanke, Ranchi 834006, Jharkhand
CIP Ranchi, Kanke, Ranchi 834006, Jharkhand
Ranchi
JHARKHAND
834006
India 
Phone  9675008762  
Fax    
Email  goluy6393@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Umesh S 
Designation  Professor, Department of Psychiatry 
Affiliation  Central Institute of Psychiatry, Ranchi 
Address  CIP Ranchi, Kanke, Ranchi 834006, Jharkhand
CIP Ranchi, Kanke, Ranchi 834006, Jharkhand
Ranchi
JHARKHAND
834006
India 
Phone  9771702403  
Fax    
Email  umesh.yes@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Umesh S 
Designation  Professor, Department of Psychiatry 
Affiliation  Central Institute of Psychiatry, Ranchi 
Address  Consultant Room, Department of Psychiatry, CIP Ranchi, Kanke, Ranchi 834006, Jharkhand
CIP Ranchi, Kanke, Ranchi 834006, Jharkhand

JHARKHAND
834006
India 
Phone  9771702403  
Fax    
Email  umesh.yes@hotmail.com  
 
Source of Monetary or Material Support  
Central Institute of Psychiatry, Ranchi,  
 
Primary Sponsor  
Name  Central Institute of Psychiatry, Ranchi 
Address  Central Institute of Psychiatry, Ranchi, Kanke, Ranchi 834006, Jharkhand, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bipin Kumar Yadav  Research Lab, Department of Psychiatry, Central Institute of Psychiatry, Ranchi  Central Institute of Psychiatry, Ranchi, Kanke, Ranchi 834006, Jharkhand
Ranchi
JHARKHAND 
9675008762

goluy6393@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, CIP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clozapine as usual group  20 patients on CLOZAPINE orally with normal vitamin D levels for 4 weeks 
Intervention  Vitamin D supplementation  20 patients on CLOZAPINE receiving Vitamin D 60K IU once a week orally for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient with diagnosis of Schizophrenia in ICD
2. Illness duration of atleast 2 years
3. Patients providing informed consent for the study  
 
ExclusionCriteria 
Details  1. Any other comorbid psychiatric diagnosis
2. Any comorbid substance use
3. Significant current or past medical illness
4. Known hypersensitivity to Vitamin D 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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)   0, 2nd and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

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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.

 
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