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CTRI Number  CTRI/2017/10/010274 [Registered on: 31/10/2017] Trial Registered Prospectively
Last Modified On: 28/10/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Vitamin D3 intake and decrease in Respiratory infections. 
Scientific Title of Study   Randomised Trial of Two Different Doses of Vitamin D Supplementation And Risk of Acute Respiratory Infection in Childrens in Rural Kolar, Karnataka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanak N Venkateshwara Prasad 
Designation  Professor 
Affiliation  Sri Devraj Urs Medical College 
Address  Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.

Kolar
KARNATAKA
563101
India 
Phone  9740551490  
Fax    
Email  drknvp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kanak N Venkateshwara Prasad 
Designation  Professor 
Affiliation  Sri Devraj Urs Medical College 
Address  Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.

Kolar
KARNATAKA
563101
India 
Phone  9740551490  
Fax    
Email  drknvp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kanak N Venkateshwara Prasad 
Designation  Professor 
Affiliation  Sri Devraj Urs Medical College 
Address  Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.

Kolar
KARNATAKA
563101
India 
Phone  9740551490  
Fax    
Email  drknvp@gmail.com  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka(Pin 563103), Kolar, karnataka, India 
 
Primary Sponsor  
Name  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar 
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 
Kanak N Venkateshwara Prasad  Sri Devaraj Urs Medical College  Department of Pediatrics, Sri Devraj Urs Medical College, SDUAHER,Tamaka, Kolar, Karnataka.
Kolar
KARNATAKA 
9740551490

drknvp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics Committee of Sri Devaraj Urs Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  3 years to 6 years age grouped healthy childrens are participated without Vitamin D deficiency 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Large Vitamin D3 supplimentary dose  Dose-3000IU, Every Day Once for 3 Months, same Dose and Frequency for another 3 months after a Intervention free period of 6 Months 
Comparator Agent  Normal Vitamin D3 supplimentary dose   Dose-600IU, Every Day Once for 3 Months, same Dose and Frequency for another 3 months after a Drug free period of 6 Months 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Healthy children by parental report. Age group of completed 3 years – 6th year running.
Present to RL Jallappaschool in Kolar. Parents provide informed consent to participate
 
 
ExclusionCriteria 
Details  Children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin D metabolism and increase the risk of respiratory infection. Child having clinical rickets. Child already on vitamin supplementation

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of Parent reported and Class teacher detected acute respiratory tract infections   upto 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Serum vitamin D levels.   Serum vitamin D levels at the time of Recuriment and at the end of each 3 Months of Vitamin D3 supplimentation. 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   12/01/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.AUTHORS: YC Manjunatha, KNV Prasad, YC Beeregowda, A Bhaskaran TITLE: Multiple Splenic Artery Aneurysms Secondary to Extra Hepatic Portal Vein Obstruction JOURNAL: J ClinDiagn Res. YEAR: 2013. 2. KNV Prasad, A Rajha, PK Vegi. A Case of Monozygotic Twins: The Value of Discordant Monozygotic Twins in Goldenhar Syndrome—OMIM%164210. Case reports in pediatrics Hindawi Publishing Corporation. 2013.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Vitamin D is known to be of physiological importance outside of bone health and calcium homeostasis, and there is mounting evidence that it plays a beneficial role in the prevention and/or treatment of a wide range of diseases.  Vitamin D appears capable of inhibiting pulmonary inflammatory responses while enhancing innate defence mechanisms against respiratory pathogens. Epidemiological studies have shown that low serum 25-hydroxyvitamin D levels are associated with a higher risk of upper and lower respiratory infections in children. This knowledge is particularly relevant and timely, because infants and children appear more susceptible to viral rather than bacterial infections in the face of vitamin D deficiency. The connection between vitamin D, infections and immune function in the paediatric population indicates a possible role for vitamin D supplementation in potential interventions and adjuvant therapies.  The ideal amount of vitamin D intake needed to prevent the adverse health conditions associated with vitamin D insufficiency/deficiency remains unclear. Disagreements on cut-off values for vitamin D sufficiency in the pediatric population likewise complicate interpretation of the recommendations. Furthermore, recommendations for increased sunlight exposure to promote adequate cutaneous vitamin D3 synthesis will need to be balanced with concerns for the risks associated with the increased time spent in the sun exposed to UV radiation. Based on currently available research, however, support for supplementation greater than what prevents the most adverse outcomes (i.e.  Severe rickets) is strongly advocated. Population-based studies showing an association between circulating vitamin D levels and lung function provide strong justification for randomized controlled clinical trials of vitamin D supplementation in patients with respiratory diseases to assess both efficacy and optimal dosage.

 

  

 

         

 

 

 

 
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