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
|
|
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
|
|
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. |