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CTRI Number  CTRI/2017/01/007636 [Registered on: 06/01/2017] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Trial 
Public Title of Study   Maternal Malnutrition and Lactation 
Scientific Title of Study   Maternal Malnutrition and Lactation Performance in India 
Trial Acronym 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunita Taneja 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sunita.taneja@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunita Taneja 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sunita.taneja@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sunita Taneja 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sunita.taneja@sas.org.in  
 
Source of Monetary or Material Support  
National Institute of Health (NIH), BETHESDA MD 20817 
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi – 110016, India  
Type of Sponsor  Research institution 
 
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 Sunita Taneja  Centre for Health Research and Development, Society for Applied Studies  Village Jatola, District Palwal, Tatarpur
Faridabad
HARYANA 
011-46043751-55
011-46043756
sunita.taneja@sas.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics review committee Centre of Health Research and Development Society of Applied Studies  Approved 
Ethics review committee Centre of Health Research and Development Society of Applied Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy mothers with breast feeding infants 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  - Married
- Non-smoking
-Women18-45 years of age with currently breastfeeding infants aged 2-4 months
 
 
ExclusionCriteria 
Details  - Participants not residing in study area for 2 weeks
- Smoker
- Non consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Lactation performance assessed by breastmilk volume body composition,Nutritional status of lactating mothers and infants,Breast milk macronutrient and micronutrient(percentage of fats, proteins, carbohydrates),Maternal micronutrient status. Immunological/inflammatory profiles of breast milk and its effect on infant, intestinal permeability.   At enrollment and on days 1,2,3,4,13 and 14 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Examine raw food, urine, breastmilk samples for mycotoxin & pesticide. Interviews & FGD with community & FLW.   At enrollment and day 14 
 
Target Sample Size   Total Sample Size="232"
Sample Size from India="232" 
Final Enrollment numbers achieved (Total)= "232"
Final Enrollment numbers achieved (India)="232" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2017 
Date of Study Completion (India) 31/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 09/09/1909 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The study will be conducted in rural areas of Haryana.  232 lactating women, 18-45 years of age with breastfeeding infants aged 2 to 4 months will be enrolled over a period of a year. At enrollment information will be obtained on socio-demographic characteristics, breast feeding practices, maternal and infant morbidity. Mothers will be administered a single dose of deuterium oxide and the appearance and subsequent disappearance of deuterium in mothers and infants will be determined by serial salivary samples. Anthropometric measurements of infants and mothers will be taken at enrollment and 2 weeks later. Breast milk and blood samples will be taken at enrollment to ascertain the macro and micro nutrient status. Infant gut permeability will be assessed 2 weeks after enrollment.

Examine mycotoxin and pesticide exposure in the breast milk of  mothers and mycotoxin exposure in infant urine in a sub sample. Also, estimate  mycotoxin and pesticide exposure in food samples of rice, maize, groundnuts, chillies, sorgum/millet, seasonally available vegetables produce and milk samples (from retailer and wholesale vendors) commonly accessed by target communities.

In-depth interviews will be conducted (n=30) with already enrolled lactating women to comprehend characteristics of  food systems, food safety and water, hygiene and sanitation access with respect to environmental exposures and dietary practices will be done. In-depth case studies (n = 15) and record GIS map for community and household food, wash access and practices will be done. Interviews with local shop owners (n =50) will be conducted for food safety practices, procurement, storage. Focus group discussions with community members (n = 10) to understand food systems affecting community members including potential routes of exposure to mycotoxins and pesticides, water, hygiene and sanitation access, use, practices and beliefs will be done.

 
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