| CTRI Number |
CTRI/2024/09/073975 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supplementary Food Products] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Efficacy of Supplementary Food Products for Malnourished Children |
|
Scientific Title of Study
|
Efficacy of Energy Dense Protein Rich Supplementary Food Products for Moderate Acute Malnourished Children of 6-59 Months |
| 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 Komal Chauhan |
| Designation |
Professor and dean research and outreach |
| Affiliation |
National Institute of Food Technology Entrepreneurship and Management |
| Address |
Department of Food Science and Technology, room no. D12, plot No. 97, sector 56 HSIIDC Industrial Estate,Kundli, District-Sonepat, Haryana-131028, India
Sonipat
HARYANA
131028
India |
| Phone |
9466000672 |
| Fax |
|
| Email |
drkomal.niftem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanya Pareek |
| Designation |
Doctoral Research Scholar |
| Affiliation |
National Institute of Food Technology Entrepreneurship and Management |
| Address |
Department of Food Science and Technology, room no. 237, plot No. 97, sector 56 HSIIDC Industrial Estate,Kundli, District-Sonepat Haryana-131028, India
Sonipat
HARYANA
131028
India |
| Phone |
7210132102 |
| Fax |
|
| Email |
vanyaofficialwork@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanya Pareek |
| Designation |
Doctoral Research Scholar |
| Affiliation |
National Institute of Food Technology Entrepreneurship and Management |
| Address |
Department of Food Science and Technology, room no. 237, plot No. 97, sector 56 HSIIDC Industrial Estate,Kundli, District-Sonepat Haryana-131028, India
Sonipat
HARYANA
131028
India |
| Phone |
7210132102 |
| Fax |
|
| Email |
vanyaofficialwork@gmail.com |
|
|
Source of Monetary or Material Support
|
| GC Rieber Compact India Private Limited, 6 IMT Manesar, Gurugram 122051, Haryana, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Food Technology Entrepreneurship and Management |
| Address |
Plot No. 97, Sector 56 HSIIDC Industrial Estate,Kundli, District-Sonepat Haryana-131028, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Union Grants Commission |
South Campus of Delhi University, Benito Jhuarez Marg, New Delhi - 110021. Near Dhola Kuan. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Komal Chauhan |
National Institute of Food Technology Entrepreneurship and Management |
Department of Food Science and Technology, room no. 237 , Plot No. 97, Sector 56 HSIIDC Industrial Estate,Kundli, District-Sonepat Haryana-131028
Sonipat
HARYANA |
9466000672
drkomal.niftem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIFTEM Ethics Committee for Human Research (NECHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control for a period of 8 weeks. |
Control given no feed maintained on normal diet for 8 weeks of period. |
| Comparator Agent |
Peanut based commercial ready-to-use supplementary food paste for a period of 8 weeks. |
Peanut based commercial ready-to-use supplementary food paste.
One packet each day for a period of 8 weeks. |
| Intervention |
Supplementary food products period of 8 weeks |
Indigenously developed energy dense protein rich supplementary food products.
One packet each day for a period of 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
59.00 Month(s) |
| Gender |
Both |
| Details |
Children between the age group of 6 and 59 months, weight-for-height Z-score between -2 and -3 (World Health Organisation, 2006, Child Growth Standards) |
|
| ExclusionCriteria |
| Details |
Children with severe acute malnutrition, a history of chronic illness, and an allergy to peanuts, wheat, soybean, or skim milk powder |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| height, weight, and hemoglobin |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increase in height, weight, hemoglobin.
Compliance and acceptability |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
23/09/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The trial entitled "Efficacy of Energy Dense Protein Rich Supplementary Food Products for Moderate Acute Malnourished Children of 6-59 Months" aims to test the efficacy of indigenous supplementary food products (intervention group) against the commercial peanut-based ready-to-use supplementary food paste (control positive group) and normal diet (control negative group). The intervention is planned for 8 weeks and aims to improve (from moderate acute malnourished to normal) the health status of malnourished children. |