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Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children

NCT01705769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 911

Last updated 2015-06-08

No results posted yet for this study

Summary

This project aims to assess the efficacy of three options under consideration in India for home management of Severe Acute Malnutrition (SAM). The investigators propose to conduct a multi-center randomized controlled trial to determine the efficacy of two community-supported home-based regimes using centrally or locally produced Ready to Use Therapeutic Foods (RUTF) for recovery from uncomplicated SAM after 16 weeks of management, compared with an augmented home-prepared foods regimen. The trial will enroll 911 children with uncomplicated SAM and will have enough statistical power to detect a 15% or greater difference in recovery rates between either one of the intervention groups compared with comparison group.

Conditions

  • Uncomplicated Severe Acute Malnutrition

Interventions

OTHER

Ready to Use Therapeutic Food-Centrally produced

Ready to Use Therapeutic Food-Centrally produced by an Indian company.

OTHER

Ready to Use Therapeutic Food-Locally produced

Ready to Use Therapeutic Food prepared by the study team

OTHER

High energy and micronutrient rich foods

High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them

Sponsors & Collaborators

  • Arth

    collaborator OTHER

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • Society for Applied Studies

    lead OTHER

Principal Investigators

  • Nita Bhandari, MD, PhD · Centre for Health Research and Development, Society for Applied Studies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705769 on ClinicalTrials.gov