| 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
|
|
|
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
|
|
|
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.
---
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. |