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CTRI Number  CTRI/2024/09/073873 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Vitamin B1 (Thiamine) Supplementation in Infants with Pulmonary Arterial Hypertension 
Scientific Title of Study   Non-Cardiac Pulmonary Arterial Hypertension in Infants Presenting with Respiratory Distress: Assessing the Efficacy of Thiamine Supplementation in a Clinical Setting 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mampy Das 
Designation  Assistant Professor 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mampy Das 
Designation  Assistant Professor 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mampy Das 
Designation  Assistant Professor 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences 
Address  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Source of Monetary or Material Support  
(Applied for Institutional Intramural grant) North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong, Mawdiangdiang, East Khasi Hills, Meghalaya - 793018, India  
 
Primary Sponsor  
Name  Individual Principal Investigator Name Mampy Das 
Address  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute of Medical Sciences, Shillong, Mawdiangdiang, East Khasi Hills, Meghalaya - 793018, India. Phone 8399870918 
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 
Dr Mampy Das  North Eastern Indira Gandhi Regional Institute Health and Medical Sciences, Shillong  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute Health and Medical Sciences, Shillong, Mawdiangdiang
East Khasi Hills
MEGHALAYA 		 8399870918

mampydas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E518||Other manifestations of thiamine deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Addition of Thiamine to Standard Care for management of Pulmonary Arterial Hypertension  Addition of Thiamine to Standard care (Oxygen/Sildenafil) Thiamine is given at a dose of 100mg/day via intravenous infusion over 60minutes for three consecutive days 
Comparator Agent  Standard Care for management of Pulmonary Arterial Hypertension  Standard care for Pulmonary Arterial Hypertension i. Oxygen therapy with flow rate titrated to target SpO2 of 90-94%. Duration is 72hours ii. Sildenafil at a dose of 0.5mg/kg/day orally for three consecutive days 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Infants aged 1month to 12months presenting with respiratory distress, as evidenced by signs such as tachypnea, retractions, grunting, or cyanosis. 
 
ExclusionCriteria 
Details  The project has two sets of exclusion criteria:
1. Exclusions before enrollment to the prevalence study:
i.Infants diagnosed with structural heart defects except a small (less than 5mm) atrial septal defect or a small (less than 2mm) patent foramen ovale.
ii. Infants diagnosed with chronic lung disease.
2. Exclusions to the intervention study:
i.Infants who have recently received supplementation with thiamine containing Multivitamins.
ii. Patient on predominantly formula feeds. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Resolution of Pulmonary Arterial Hypertension  At 72 hours  
 
Secondary Outcome  
Outcome  TimePoints 
Impact of thiamine supplementation on clinical outcomes, including oxygenation and heart rate  At 72 hours 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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   Phase 2 
Date of First Enrollment (India)   11/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mampydas@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The project aims to investigate the efficacy of thiamine supplementation in resolving non-cardiac Pulmonary Arterial Hypertension (PAH) in infants with respiratory distress. Conducting a randomized controlled trial (RCT) in Northeast India, where there’s a lack of data, the study seeks to establish a causal relationship between thiamine supplementation and PAH resolution. By addressing confounding factors and measuring thiamine levels, the research aims to influence clinical decision-making, potentially establishing thiamine supplementation as a standard therapeutic approach for non-cardiac PAH in infants, thus improving patient outcomes and care quality.  Our Research hypothesis is that â€œA significant proportion of infants aged 1month to 12months admitted to our tertiary care hospital presenting with respiratory distress (P) have pulmonary arterial hypertension (PAH) of non-cardiac origin, which have good response to thiamine supplementation (I) leading to a higher rate of resolution of PAH (O) at the end of 72hours (T) within the designated study period compared to infants receiving standard care alone (C).” 


 
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