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CTRI Number  CTRI/2017/01/007751 [Registered on: 31/01/2017] Trial Registered Retrospectively
Last Modified On: 26/12/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of zinc supplementation to antidepressant therapy in patients with unipolar depression 
Scientific Title of Study   Effect of zinc supplementation on antidepressant therapy and serum zinc level in unipolar depression:A randomized double blind 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 DILEEP KR VERMA 
Designation  Resident 
Affiliation  CENTRAL INSTITUTE OF PSYCHIATRY 
Address  MILLAT COLONY, KANKE, RANCHI
CENTRAL INSTITUTE OF PSYCHIATRY,KANKE,RANCHI
Ranchi
JHARKHAND
834006
India 
Phone  07091768783  
Fax    
Email  dr.dileep09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Basudeb Das 
Designation  Professor Of Psychiatry 
Affiliation  CENTRAL INSTITUTE OF PSYCHIATRY 
Address  CENTRAL INSTITUTE OF PSYCHIATRY,KANKE, RANCHI

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

Ranchi
JHARKHAND
834006
India 
Phone    
Fax    
Email  basudeb71@gmail.com  
 
Source of Monetary or Material Support  
Central Institute of Psychiatry, kanke, Ranchi, 834006 
 
Primary Sponsor  
Name  None 
Address  NA 
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 
Dr DILEEP KUMAR VERMA  CENTRAL INSTITUTE OF PSYCHIATRY  KANKE,RANCHI
Ranchi
JHARKHAND 
07091768783

dr.dileep09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, C.I.P., Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Unipolar depression,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Only on antidepressants for 8 weeks 
Intervention  zinc  zinc 20mg OD for 08 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of depressive episode and recurrent depressive disorder according to ICD-10 DCR (WHO, 1993).
2.Status of patient should be drug naïve or drug free for minimum 2 weeks.
3.Patients giving written informed consent.
 
 
ExclusionCriteria 
Details  1.Presence of comorbid psychiatric disorder.
2.Individuals with history of substance use meeting dependence criteria, other than nicotine and caffeine.
3.Co-morbid medical illness known to affect zinc level including acute or chronic inflammatory disorder and neurological disorder.
4.ECT during index episode.
5.Patient on multivitamin supplementation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
MEAN HAMILTON DEPRESSION SCORE AND MEAN BECK DEPRESSION SCORE  BASELINE,2 WEEK,4 WEEK & 8 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
MEAN SERUM ZINC,ALBUMIN AND C-REACTIVE PROTEIN LEVEL  BASELINE,2 WEEK,4 WEEK & 8 WEEK 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="20" 
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 was a hospital based double blind randomised controlled trial conducted at Central Institute of Psychiatry (CIP), Ranchi between September 2013 and January 2015. Aimed to assess the efficacy of zinc supplementation as an intervention for depressive symptoms, difference in zinc levels before and after treatment and to assess correlation of zinc level with albumin and C-RP. Subjects were recruited into two groups by simple random sampling technique using computer generated randomization. Sample size was consisted of 60 drug naïve (or drug free for minimum 2wks) cases of depressive episode or recurrent depressive disorder according to ICD-10 and fulfilling inclusion and exclusion criteria’s and all subjects gave informed consent. Detailed socio-demographic and clinical data was collected for every subjects. Baseline weight, basal metabolic rate (BMI-Kg/m2), blood pressure recorded after that clinical scales (HAM-D, BDI, BPRS, BSSI, SES, HAM-A, CGI, UKU) were applied in our study on patients to assess baseline status. Blood samples was drawn to assess baseline complete hemogram, LFT, RFT, TFT, FBS, lipid profile along with serum zinc, C–RP and albumin. For patients selected for zinc supplementation, 20mg of elemental zinc daily was given along with antidepressants and other group was without zinc supplementation, rater was kept blind. Blood tests and clinical assessment was repeated after 2, 4 & 8 wks. Serum zinc measurement was done by chemistry analysis (semi-automated method) (normal reference range 60-120 µg/dl). Serum albumin by Bromo Cresol Green Method (normal reference range 3.5-5.5 mg/dl). C-reactive protein by Latex agglutination method (semi quantitative test) (normal<5mg/L).

 
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