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CTRI Number  CTRI/2017/07/009136 [Registered on: 27/07/2017] Trial Registered Retrospectively
Last Modified On: 16/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Vitamin D supplementation in treatment of First episode Psychosis 
Scientific Title of Study   Effect of Vitamin D supplementation in treatment of First Episode Psychosis: A Randomised double blind, placebo controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SATYAM KISHORE 
Designation  Resident 
Affiliation  Central Institute of Psychiatry, Ranchi, Jharkhand 
Address  Married quarter no. 12, Post Graduate hostel, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India

Ranchi
JHARKHAND
834006
India 
Phone  8521396648  
Fax    
Email  sksrivastava1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Basudeb Das 
Designation  Professor of Psychiatry 
Affiliation  Central Institute of Psychiatry, Ranchi, Jharkhand 
Address  CENTRAL INSTITUTE OF PSYCHIATRY,KANKE, RANCHI Ranchi JHARKHAND 834006 India

Ranchi
JHARKHAND
834006
India 
Phone  9431108544  
Fax    
Email  basudeb71@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Basudeb Das 
Designation  Professor of Psychiatry 
Affiliation  Central Institute of Psychiatry, Ranchi, Jharkhand 
Address  CENTRAL INSTITUTE OF PSYCHIATRY,KANKE, RANCHI Ranchi JHARKHAND 834006 India

Ranchi
JHARKHAND
834006
India 
Phone  9431108544  
Fax    
Email  basudeb71@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL INSTITUTE OF PSYCHIATRY, KANKE, RANCHI, JHARKHAND-834006 
 
Primary Sponsor  
Name  Central Institute of Psychiatry 
Address  Kanke, ranchi, Jharkhand, India-834006 
Type of Sponsor  Government medical college 
 
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 
SATYAM KISHORE  CENTRAL INSTITUTE OF PSYCHIATRY  MAUDSLEY WARD, KRAEPLIN WARD, CONOLLY WARD, TUKE WARD, L.P. VERMA WARD, BERKELEY HILL WARD, FRUED WARD, JUAN WARD, PATHOLOGY DEPARTMENT atCENTRAL INSTITUTE OF PSYCHIATRY, KANKE
Ranchi
JHARKHAND 		 91-8521396648

sksrivastava1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, CIP, Ranchi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F23||Brief psychotic disorder, First Episode PSychosis, (2) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (3) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (4) ICD-10 Condition: F200||Paranoid schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo tablet similar in shape, size, color, taste to active Vitamin D tablet and from same manufacturer  Placebo administered daily along with psychotropic medication 
Intervention  Vitamin D tablets  Vitamin D supplementation in dose of 2000 IU/day alongwith psychotropic medication 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Either sex.
2. Age: 18-45 years.
3. Diagnosed cases of a. Schizophrenia (all subtypes) b. Mania with psychotic symptoms c. Severe Depression with psychotic symptoms d. Acute & Transient Psychotic Disorder ; fulfilling ICD-10 DCR (WHO, 1993) criteria.
4. Status of patient should be drug naïve (or drug free for minimum 4 weeks for oral psychotropic medications & 8 weeks for depot preparations).
5. Patients giving written informed consent.  
 
ExclusionCriteria 
Details  1. Presence of co-morbid psychiatric disorder. 2. Individuals with history of substance use meeting dependence criteria, other than nicotine & caffiene.
3. Co-morbid medical illness known to affect Vit.D level (Arthritis, Osteoporosis, Rickets, End Stage Renal Disease, Malabsorption Syndromes, Corticosteroid therapy).
4. Patients already on Vitamin D supplementation.
5. Patients receiving anticonvulsant medications as mood stabilizer.
6. Patients with BMI more than 30kg/m².
7. Menopausal females.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Brief Psychiatric rating scale, Positive and Negative Syndrome scale, Young Mania rating scale, Hamilton Rating scale for Depression   Baseline and at 4 weeks completion 
 
Secondary Outcome  
Outcome  TimePoints 
Serum Vitamin D level  Baseline and at 4 weeks completion 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/12/2015 
Date of Study Completion (India) 20/06/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is a randomised, double blind, placebo controlled, hospital based study. The subjects were recruited for the study by simple random sampling technique. Sample size consisted of 60 diagnosed drug naive( or drug free for a minimum of 4 weeks in case of oral psychotropic medication & 8 weeks for depot preparations) cases of First episode psychosis according to ICD-10 DCR. For those patients selected for vitamin D supplementation, 2000 IU/day of vitamin D along with regular psychotropic medications were given and the other group was treated with placebo and regular psychotropic medications. Blood sample examination for various parameters and clinical assessment were done at baseline and again at completion of 4 weeks. Serum vitamin D estimation was done by ELISA method. 
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