FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/068448 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Quality Analysis of First Human milk (Colostrum) and Its Relation with the Diet of Mothers and the Role of Breastfeeding on their Infants. 
Scientific Title of Study   An Analytical Study on the Immuno-nutritional Attributes of Human Colostrum in Relation to the Diet and Well-being of Nursing Mothers and its Impact on their Infants 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Sukanya Chakravorty 
Designation  Assistant Professor  
Affiliation  Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University 
Address  Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8005231237  
Fax    
Email  su.chakravorty@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  DrSukanya Chakravorty 
Designation  Assistant Professor  
Affiliation  Mahila Mahavidyalaya, Banaras Hindu University 
Address  Department of Home Science Mahila Mahavidyalaya, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8005231237  
Fax    
Email  su.chakravorty@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Aishwarya Das 
Designation  Research Scholar  
Affiliation  Mahila Mahavidyalaya, Banaras Hindu University 
Address  Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8420400601  
Fax    
Email  aishwarya1995@bhu.ac.in  
 
Source of Monetary or Material Support  
Department of Clinical Biochemistry, Institute of Medical Sciences, Banaras Hindu University 
Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University 
Indian Medicine Wings, Sir Sunderlal Hospital, Banaras Hindu University 
UGC Non-NET Fellowship, Banaras Hindu University  
 
Primary Sponsor  
Name  DrSukanya Chakravorty 
Address  Assistant Professor, Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi  
Type of Sponsor  Other [Self] 
 
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 
ProfDr Deepa Mishra  Prasuti Vibhag, Indian Medicine Wings, Sir Sunderlal Hospital  Banaras Hindu University, Varanasi, Uttar Pradesh-221005
Varanasi
UTTAR PRADESH 		 9650453095

deepa1971mishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Institute of Science, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant and Lactating 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Lactating mothers who will give birth in the Indian Medicine Wings of Sir Sunderlal Hospital, Banaras Hindu University and their neonates. 
 
ExclusionCriteria 
Details  1) Mothers with Communicable Diseases and neonates who requires immediate neonatal care.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There will be a significant association between mothers diet with the Immuno-nutritional attributes of the colostrum  1.5 years 
 
Secondary Outcome  
Outcome  TimePoints 
Health of the infants will be positively affected by the feeding of colostrum and Exclusive Breast Feeding  1.5 years 
 
Target Sample Size   Total Sample Size="390"
Sample Size from India="390" 
Final Enrollment numbers achieved (Total)= "195"
Final Enrollment numbers achieved (India)="195" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/06/2024 
Date of Study Completion (India) 10/04/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Pregnancy is the crucial phase of life of a women  where numerous changes occurs in the mothers’ and each of changes affects their babies in different ways. In the developing countries like India, the survival of an infant is still a challenge. Major reason behind infant mortality is malnutrition, growth failure and immunity related issues. It has been proved that colostrum, the first yellow milk, acts as the early vaccination against various diseases for the infants. The present study aims to focus on the dietary intake of pregnant mothers and to find the association between the diet and the immuno-nutritional attributes, for instance Protein, IgA, IgG and Lactoferrin content of the colostrum . This study will also assess the impact of colostrum feeding and Exclusive Breast Feeding on the health of the infants. For the present study colostrum will be collected from the mothers and analyzed for their contents. The present study will promote proper breast feeding practices and also on balanced diet for lactating mothers which will be beneficial for both the mother and child.
 
 
Close