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CTRI Number  CTRI/2013/01/003317 [Registered on: 23/01/2013] Trial Registered Retrospectively
Last Modified On: 17/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Vitamin D Supplementation for Severe Pneumonia in Under-five Children 
Scientific Title of Study   Vitamin D Supplementation for Severe Pneumonia in Under-five Children: A Double Blind, Randomized Placebo Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Piyush Gupta 
Designation  Professor 
Affiliation  University College of Medical Sciences 
Address  Department Of Pediatrics University College of Medical Sciences & GTB Hospital Delhi
R6A Dishad Garden Shahdara Delhi 110095
East
DELHI
110095
India 
Phone  9811597172  
Fax    
Email  prof.piyush.gupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Piyush Gupta 
Designation  Professor 
Affiliation  University College of Medical Sciences 
Address  Department Of Pediatrics University College of Medical Sciences & GTB Hospital Delhi
R6A Dishad Garden Shahdara Delhi 110095
East
DELHI
110095
India 
Phone  9811597172  
Fax    
Email  prof.piyush.gupta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Piyush Gupta 
Designation  Professor 
Affiliation  University College of Medical Sciences 
Address  Department Of Pediatrics University College of Medical Sciences & GTB Hospital Delhi
R6A Dishad Garden Shahdara Delhi 110095
East
DELHI
110095
India 
Phone  9811597172  
Fax    
Email  prof.piyush.gupta@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
Type of Sponsor  Government funding agency 
 
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 
Prof Piyush Gupta  University College of Medical Sciences  Department of Pediatrics Room No 1223 (ward 12) Dilshad Garden
East
DELHI 		 09811597172

prof.piyush.gupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University College of Medical Sciences, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  pneumonia, (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Identically colored and packaged inert powder single dose at enrolment 
Intervention  vitamin D   Single oral dose of 100,000 IU at enrolment 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children with severe pneumonia 
 
ExclusionCriteria 
Details  Exclusion criteria
1. Children who have received vitamin D or calcium supplements within last 4 weeks, as ascertained on verbal enquiry (ingestion of oral formulation as sachets/granules or syrups or tablets). Where ever possible the parents will be asked to show the prescription of the physician or empty bottles, sachets or tablets consumed by the child.
2. Children with clinical features of rickets
3. Children with severe malnutrition (weight for height less than -3 SD of WHO standards or presence of bipedal edema)
4. Known asthmatics
5. Those with complicated pneumonia (lung abscess, pleural effusion, empyema) or illness severe enough to require ventilation.
6. Those suffering from any chronic respiratory disease including respiratory tract malformations and chest wall deformities, heart disease (congenital/acquired), renal or hepatic insufficiency, neurological illness resulting in abnormalities of muscle tone/power
7. Those known to have hypercalcemia or allergy to vitamin D
8. Children immunized with pneumococcal/flu vaccine
9. Known immunodeficiency
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Time to resolution of severe pneumonia: The duration from the enrolment till the chest indrawing is no longer present, and continue to be absent for next 24 hours.
2. Proportion of children having a repeat episode of pneumonia in next six months.

 		 1. 7 days
2. 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in serum levels of cathelicidin   72 hours 
Change in serum levels of immunoglobulins (Ig A, IgG, IgM)   72 hours 
Duration of hospitalization  At discharge 
Time to complete recovery from pneumonia (Normalization of RR)  7 days 
Fever clearance time  7 days 
Failure rate (Non-response after 48 hours of antibiotic therapy)  48 hours 
Time to start oral feeds  7 days 
 
Target Sample Size   Total Sample Size="324"
Sample Size from India="324" 
Final Enrollment numbers achieved (Total)= "324"
Final Enrollment numbers achieved (India)="324" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/07/2012 
Date of Study Completion (India) 27/08/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/08/2015 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Gupta P, Dewan P, Shah D, Sharma N, Bedi N, Kaur IR, Bansal AK, Madhu SV. Vitamin D Supplementation for Treatment and Prevention of Pneumonia in Under-five Children: A Randomized Double-blind Placebo Controlled Trial. Indian Pediatr. 2016 Nov 15;53(11):967-976. doi: 10.1007/s13312-016-0970-5. PMID: 27889723. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Objective: To evaluate the efficacy of single oral mega-dose of Vitamin D3 for treatment and prevention of pneumonia in under-five children.

Design: Randomized, double blind, placebo-controlled trial.

Setting: Tertiary-care hospital.

Participants: 324 children (of 980 assessed) between 6 mo-5 y age (median (IQR): 12 (7,19.8) mo) with WHO-defined severe pneumonia. Of these, 126 (39%) were vitamin D deficient (serum 25(OH)D <12 ng/mL).

Intervention: 100,000 IU of oral cholecalciferol (n= 162) or placebo (n= 162) in single dose, administered at enrolment. Outcome variables: Primary: Time to resolution of severe pneumonia and proportion of children having recurrence of pneumonia in next 6 months; Secondary: Change in serum levels of 25(OH)D; immunoglobulins IgA, IgG, IgM, and cathelicidin 2 weeks following supplementation; and time taken for overall resolution of illness.

Outcome variables: Primary: Time to resolution of severe pneumonia and proportion of children having recurrence of pneumonia in next 6 months; Secondary: Change in serum levels of 25(OH)D; immunoglobulins IgA, IgG, IgM, and cathelicidin 2 weeks following supplementation; and time taken for overall resolution of illness.

Results: Median (95% CI) time for resolution of severe pneumonia was 30 (29, 31) h in the vitamin D group as compared to 31 (29,33) h in the placebo group [adjusted hazard ratio (95% CI): 1.39 (1.11, 1.76); P = 0.005]. The risk of recurrence of pneumonia in next 6 months was comparable in the two groups [placebo: 36/158 (22.8%); vitamin D: 39/156 (25%); RR (95% CI): 1.13 (0.67,1.90); P 0.69]. Proportion of vitamin D deficient children declined from 38% to 4% in the supplementation group, and from 41% to 33% in the placebo group, two weeks after supplementation. There was no significant effect of vitamin D supplementation on serum levels of cathelicidin, IgA and IgG. The time taken for complete recovery from pneumonia, duration of hospitalization, and fever clearance time were comparable for the two groups. No adverse event was noted related to the intervention.

Conclusion: There is no robust evidence of a definite biological benefit, either for therapy or prevention, to suggest a routine megadose supplement of vitamin D3 for under-five children with severe pneumonia.

 
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