Evaluating different options of supplementary food for malnourished Anganwadi going children in selected Anganwadis in Mumbai Suburbs

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2019/05/019023
• Date of registration: 09-05-2019
• Prospective Registration: Yes
• Primary sponsor: IITBombay Internal funds for M Tech study
• Public title: Evaluating different options of supplementary food for malnourished Anganwadi going children in selected Anganwadis in Mumbai Suburbs
• Scientific title: Open label, Randomised Actively-Controlled Trial, Comparative Study between ready-to-use supplementary food developed at Sion Nutrition Rehabilitation Centre and ladoos by Siddhi Vinayak Trust (SVT) in order to check the efficacy with the context of physical and functional recovery of moderately malnourished children
• Date of first enrolment: 13-05-2019
• Target sample size: 90
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=33331
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Other Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Mr Pratyush Mohanta
• Affiliation: IIT Bombay

• Name: Prof Narendra G Shah
• Affiliation: IIT Bombay

Key inclusion & exclusion criteria

Inclusion criteria: Should be between the age of 36-59 months of age. Should fall under the MAM category as per the standards set by WHO .i.e between the z-scores of -2 and -3 of weight-for-height charts.
Exclusion criteria: Any medical complications â??Severe medical illness using IMCI criteria

Any child between 36 months and 60 months who has No suitable or willing caretaker



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: E440- Moderate protein-calorie malnutrition

Intervention(s)

Intervention1: Food Supplementation: 1) Boondi Laddoo (55 gms containing 245 Kcal, 2.8 g of proteins per day)
2) Soy based RUSF(45 g containing 245 Kcal, 6.6 g proteins per day). Spot feeding, 7 days a week for 12 Weeks.



Control Intervention1: Hot Cooked Meal
: Supplementation currently provided through ICDS, Hot Cooked Meal given 6 days/wk.

Primary Outcome(s)

To evaluate status change, if any, of MAM children based on their Anthropometry Data

Timepoint: After 3 months of administering the Supplementation designed

Secondary Outcome(s)

To correlate the improvement in nutritional status of MAM children after administration of Soy based RUSF and Laddu.Timepoint: 3 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

IITBombay Internal funds for material support from Department, CTARA, IIT Powai, Mummbai 400076

Ethics review

Status: Approved
Approval date: 18/01/2019
Contact:

Ethics Committee IIT Bombay