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CTRI Number  CTRI/2022/03/040892 [Registered on: 08/03/2022] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to study the role of Vitamin B3 in recovery of patients having Acute Kidney Injury  
Scientific Title of Study   Niacinamide and renal recovery in community acquired AKI: feasibility 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 Vivek Kumar  
Designation  Associate Professor  
Affiliation  PGIMER  
Address  Department of Nephrology Level 1 C block PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  7087429731  
Fax    
Email  enigma165@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HS KOHLI 
Designation  Professor 
Affiliation  PGIMER  
Address  Department of Nephrology Level 1 C block PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9417525285  
Fax    
Email  kohlihs2009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sahil  
Designation  Senior Resident  
Affiliation  PGIMER  
Address  Department of Nephrology Level 1 C block PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9717725428  
Fax    
Email  missionpmt.cool11@gmail.com  
 
Source of Monetary or Material Support  
Department of Nephrology PGIMER, Chandigarh  
 
Primary Sponsor  
Name  Department of Nephrolog  
Address  Nehru Hospital Level 1 C- Block  
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 
sahil garg   nehru hospital   EMOPD, EMward22, Medical wards and Gynae ward Nehru Hospital Department of Nephrology, PGIMER
Chandigarh
CHANDIGARH 		 9717725428

missionpmt.cool11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER (Institutional Ethics Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  niacinamide   Vitamin b3 formulation niacinamide will be used. niacinamide will be administered 500 mg twice daily for 14 days in testing arm.  
Comparator Agent  Standard Care   IVC guided fluids and adequate perfusion avoidance of nephrotoxic drugs and agents monitoring urine output, blood gas analysis and oft  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age between 18 – 70 years
Diagnosis of community-acquired AKI
 
 
ExclusionCriteria 
Details  Pre-existing CKD with baseline CKD EPI eGFR<60ml/min/1.73m2 prior to the onset of illness.
High likelihood of underlying CKD as determined by treating physician based on clinical and laboratory parameters.
Suspected or biopsy proven glomerulonephritis as a cause of AKI.
Obstructive nephropathy as a cause of AKI.
Solid-organ or bone marrow transplant recipients.
High likelihood of re-hospitalization or death in the following 4 months as ascertained by treating physician.
Suspected or diagnosed case of decompensated chronic liver disease or AST/ ALT more than 5 times of upper limit of normal.
Suspected or diagnosed case of heart failure with functional class 3 or 4.
Past or present diagnosis of malignancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome measure will be the renal recovery at 4-month in patients having community-acquired AKI  4 month  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measures will include
a. all-cause mortality
b. urine quinolate to tryptophan ratio after niacinamide supplementation

Safety outcome measures will include:
a. side effects of niacinamide
b. hypersensitivity reaction after administration of intervention drug
 		 1 month and 4 month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/03/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Acute kidney injury (AKI) is a rising global health concern. The global incidence of AKI is increasing and could be attributed to an increase in cases of sepsis, rising comorbidities, increasing age of the population, and increased use of medications(1). The epidemiology of AKI varies depending on development status, climate and ethnicity. In developed countries, AKI is usually seen in urban intensive care units (ICU) and is associated with multiorgan failure (MODS), sepsis, and increasing age. While in developing countries, AKI in urban areas might be similar to developed countries but in rural areas, it is usually community-acquired and associated with infections, envenomation, diarrhea, and generally more common in the younger population(2, 3). Patients with AKI requiring dialysis have increased mortality and progression to end-stage renal disease (ESRD)(4). The ability to forecast renal recovery in an individual patient will help in clinical decision making and to facilitate clinical research in this field. The management of AKI targets the prevention of AKI and supportive therapy if AKI develops. The exact pathophysiological mechanism of the worsening of AKI could help in developing novel medications that can hamper the progression of AKI and thus improve the long-term outcome of AKI. 

Several biomarkers and treatment modalities were investigated for early detection and treatment of AKI respectively. But till today management of AKI is supportive. New interest has been seen in the last few years in the field of NAD+ biosynthesis with impairment of its biosynthesis and rise in quinolinate in urine found in AKI patients. Urinary quinolinate /tryptophan was found to predict AKI and other adverse outcomes in animal studies and also in critically ill patients. This hypothesis has been applied in various studies to treat AKI with nicotinamide(5). Niacinamide bypasses the salvage denovo pathway and produces NAD. In this present study we are planning to study the role of vitamin B3 in renal recovery of patients having community acquired AKI. 

 
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