FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066756 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see the effect of calcium and vitamin D supplementation on the progression of dengue fever to dengue shock syndrome and dengue hemorrhagic fever, 
Scientific Title of Study   A randomized placebo controlled study evaluating the effect of calcium and vitamin D supplementation on the progression of dengue fever to dengue shock syndrome and dengue hemorrhagic fever 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Milind Raj Nagvanshi 
Designation  medicine resident 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE AMU ALIGARH 
Address  Department of medicine jawaharlal nehru medical college aligarh Muslim university aligarh , 202001

Aligarh
UTTAR PRADESH
202001
India 
Phone  8419051230  
Fax    
Email  milindrajnagvanshi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Haider Husaini 
Designation  Assistant professor  
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE AMU ALIGARH 
Address  Department of medicine jawaharlal nehru medical college aligarh Muslim university aligarh , 202001

Aligarh
UTTAR PRADESH
202001
India 
Phone  8958786889  
Fax    
Email  dr.haiderhusaini2k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Milind Raj Nagvanshi 
Designation  medicine resident 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE AMU ALIGARH 
Address  Department of medicine, ward 11; 12 , jawaharlal nehru medical college and hospital Aligarh Muslim University
Department of medicine critical care ward Jawaharlal Nehru medical college and hospital Aligarh Muslim University
Aligarh
UTTAR PRADESH
202001
India 
Phone  8419051230  
Fax    
Email  milindrajnagvanshi@gmail.com  
 
Source of Monetary or Material Support  
Self  
 
Primary Sponsor  
Name  MILIND RAJ NAGVANSHI 
Address  JAWAHARLAL NEHRU MEDICAL COLLEGE AMU ALIGARH  
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 
Milind raj nagvanshi  Jawaharlal Nehru medical college and hospital Aligarh Muslim University   Department of medicine, ward 11,12, critical care ward
Aligarh
UTTAR PRADESH 		 8419051230

milindrajnagvanshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Jawaharlal Nehru medical college and hospital Aligarh Muslim University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:A90||Dengue fever [classical dengue]. Ayurveda Condition: DANDAKAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium supplement group   Calcium carbonate 500mg 2 times a day for 15 days 
Comparator Agent  Placebo group   Placebo drug once daily 
Intervention  Vitamin D group  Capsules Vitamin D 4000 unit once daily for 15 days 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  Patient with acute dengue fever confirmed by lab investigations , all patients wiling to give informed consent, all acute dengue fever patient admitted to medicine wards /CCW/ICU at jnmch 
 
ExclusionCriteria 
Details  Age more than 60 yr and pregnant females, patient presenting with dengue shock syndrome and dengue hemorrhagic fever, diagnosed comorbid conditions like known case of Type2DM, syst HTN,cancer,active TB, hyperparathyroidism,hypothyroidism,osteoporosis,CKD,CLD,COPD,CAD,CARDIOMYOPATHY,MALABSORPTION,history of allergy from study medication, patients not giving consent for study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
TO EVALUATE THE EFFECT OF CALCIUM AND VITAMIN D SUPPLEMENTATION ON ADMITTED ACUTE DENGUE FEVER PATIENT ON THEIR PROGRESSION TO DSS AND DHF  TO EVALUATE THE EFFECT OF CALCIUM AND VITAMIN D SUPPLEMENTATION ON ADMITTED ACUTE DENGUE FEVER PATIENT ON THEIR PROGRESSION TO DSS AND DHF 
 
Secondary Outcome  
Outcome  TimePoints 
Progressive worsening of thrombocytopenia,major and minor bleeding episodes,hepatopathy,hypocalcemia,shock,respiratory failure,acute kidney injury,cardiac arrhythmias,encephalopathy,capillary leakage   Progressive worsening of thrombocytopenia,major and minor bleeding episodes,hepatopathy,hypocalcemia,shock,respiratory failure,acute kidney injury,cardiac arrhythmias,encephalopathy,capillary leakage  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   24/07/2024 
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="1"
Months="9"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Self

  6. For how long will this data be available start date provided 03-10-2023 and end date provided 03-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 IT IS A RANDOMISED PLACEBO CONTROLLED STUDY EVALUATING THE EFFECT OF CALCIUM AND VITAMIN  D SUPPLEMENTATION ON THE OUTCOME OF DENGUE FEVER . IT IS A PROSPECTIVE , DOUBLE BLINDED ,PLACEBO CONTROLLED SINGLE CENTRE RANDOMIZED CONTROL TRIAL
ALL RANDOMIZED ADMITTED PATIENTS OF DENGUE FEVER WILL BE PLACED EITHER ON ORAL CALCIUM 500MG BD FOR 15 DAYS OR ORAL CHOLECALCIFEROL4000 IU PER DAY FOR 15 DAYS FROM DATE OF ADMISSION ALONG WITH STANDARD THERAPY
 
Close