| CTRI Number |
CTRI/2024/06/068498 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supplementation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pearl Millet and Ready-to-Use Foods in Malnourished children |
|
Scientific Title of Study
|
Effect of Pearl millet (Bajra) supplementation VS Ready to use supplementary food on the growth of children with moderate acute malnutrition |
| 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 Ishani Jha |
| Designation |
Post Graduate Resident |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Pediatrics University College of Medical Sciences & Guru Teg Bahadur Hospital East Delhi 110095 India
North East
DELHI
110095
India |
| Phone |
8130028757 |
| Fax |
|
| Email |
ishanijha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Narang |
| Designation |
Director Professor Department of Pediatrics |
| Affiliation |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
| Address |
Department of Pediatrics University College of Medical Sciences & Guru Teg Bahadur Hospital East Delhi 110095 India
East
DELHI
110095
India |
| Phone |
9811036569 |
| Fax |
|
| Email |
manish_2710@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ishani Jha |
| Designation |
Post graduate Department of Pediatrics |
| Affiliation |
University College of Medical Sciences & Guru Teg Bahadur Hospital |
| Address |
Room no 10, Paeds OPD, Department of Pediatrics University College of Medical Sciences & Guru Teg Bahadur Hospital East Delhi 110095 India
East
DELHI
110095
India |
| Phone |
8130028757 |
| Fax |
|
| Email |
ishanijha@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
Dilshad Garden, East Delhi 110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Ishani Jha |
UCMS & GTB Hospital |
University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, New Delhi- 110095
North East
DELHI
East
DELHI |
8130028757
ishanijha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Human Researc University College of Medical Sciences University of Delhi Delhi 110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pearl millet (Bajra) supplementation |
Daily Pearl millet (Bajra)supplementation for three months |
| Comparator Agent |
Ready to use supplementary food |
Daily RUSF supplementation for three months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children (aged 2 - 5 years) with moderate acute malnutrition according to the WHO criteria |
|
| ExclusionCriteria |
| Details |
Children with known chronic systemic disease, congenital malformations, chromosomal anomalies, inborn errors of metabolism, already on / history of iron supplementation in preceding 4 weeks, children with mothers having understanding issues due to language barrier
• Children with mothers not having primary education
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the recovery rate in 2-5 years old children with moderate acute malnutrition receiving Pearl millet (Bajra)-based diet supplementation with those receiving RUSF |
At baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) Change in hemoglobin level (2) Average time required for recovery
(3) Proportion of children relapsed at 6 months from enrolment
(4) Compliance and caregiver satisfaction (Likert scale) |
At baseline, 3 months , 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/06/2024 |
| 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="1"
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 study aims to evaluate the effect of pearl millet supplementation on the growth of 2–5-year-old children with moderate acute malnutrition (MAM). It primarily compares the recovery rate, measured by the change in weight-for-height Z-score, between children receiving pearl millet-based supplementation and those receiving ready-to-use supplementary food (RUSF) over three months. Secondary objectives include comparing changes in hemoglobin levels, recovery time, relapse rates within six months, and caregiver satisfaction. Conducted at UCMS & GTB Hospital in Delhi, this open-label randomized controlled trial involves 120 children, divided into two groups. Anthropometric measurements and hemoglobin levels will be assessed at baseline and after three months, with follow-ups to monitor progress and compliance. |