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CTRI Number  CTRI/2017/08/009258 [Registered on: 03/08/2017] Trial Registered Retrospectively
Last Modified On: 02/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Food based nutritional supplementation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study nutritional status and body composition of underprivileged lactating mothers and growth of their infants  
Scientific Title of Study   Linkages of nutritional status and body composition of underprivileged lactating mothers and growth of their infants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha V Khadilkar 
Designation  Deputy Director 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute  
Address  Hirabai Cowasji Jehangir Medical Research Institute, Lower ground floor, Jehangir Hospital, 32, Sassoon Road, Pune Pune MAHARASHTRA India

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  anuradhavkhadilkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anuradha V Khadilkar 
Designation  Deputy Director 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute  
Address  Hirabai Cowasji Jehangir Medical Research Institute, Lower ground floor, Jehangir Hospital, 32, Sassoon Road, Pune Pune MAHARASHTRA India

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  anuradhavkhadilkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anuradha V Khadilkar 
Designation  Deputy Director 
Affiliation  Hirabai Cowasji Jehangir Medical Research Institute  
Address  Hirabai Cowasji Jehangir Medical Research Institute, Lower ground floor, Jehangir Hospital, 32, Sassoon Road, Pune Pune MAHARASHTRA India

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  anuradhavkhadilkar@gmail.com  
 
Source of Monetary or Material Support  
Hirabai Cowasji Jehangir Medical Research Institute HCJMRI, 32, Sassoon road, Jehangir Hospitals , Pune , 411001 
 
Primary Sponsor  
Name  Hirabai Cowasji Jehangir Medical Research Institute  
Address  Lower ground floor, Jehangir hospital, 32, Sassoon Road,Pune - 411001  
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 Anuradha Khadilkar  Hirabai cowasji jehangir medical research institute , HCJMRI, Jehangir Hospital  Growth and Endocrine Unit, Lower Ground Floor.
Pune
MAHARASHTRA 
020-26141340

anuradhavkhadilkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JCDC Ethics Committee Jehangir Clinical Development Centre Pvt. Ltd.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For improving the nutritional status of lactating mothers .  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Food based supplement   Ready to eat snack will be prepared and distributed to the enrolled lactating mothers. dose: 160 gms of supplemental powder frequency: Daily once route of administration : orally TOTAL duration of therapy: 6 months post lactation  
Comparator Agent  Standard care   Standard care will be continued to other group  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Apparently healthy lactating mothers (within 30 days of delivery), not ill since last 15 days from date of interview and willing for informed consent will be recruited for the study. 
 
ExclusionCriteria 
Details  Pre existing diseases like hyper thyrioidism / GDM / pre-eclumsia/ Mothers with seriously ill babies (IUGR/ SGA)  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
BMI  Baseline and endline 
 
Secondary Outcome  
Outcome  TimePoints 
Bone Mineral Content  Baseline and endline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/02/2016 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Women from lower socioeconomic class are exposed to adolescent pregnancies and also longer breastfeeding period. At the same time they are also subjected to compromised food intake due to various reasons.  These women also accrue less peak bone mass, and are more at risk for developing low bone status at later age of life due to multiple pregnancies and constant state of under nutrition. To overcome the nutritional deficiency ICDS provides the take home ration (THR) during pregnancy and lactation. However because of raw form, the compliance for intake of THR is poor. Also studies examining the maternal health status, intake of THR and its effect on body composition of mother as well as her infant post supplementation are scarce. In addition, because of teen age pregnancy, multiparity and prolonged breast feeding risk of developing low bone mass                 (osteoporosis) increases. Hence, a need for further research into the relationship between nutritional status, lactation, changes in maternal body composition in light of the supplementation and effect of adolescent pregnancy on later age osteoporosis is strongly felt. 

 
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