Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children
SAMPOORNA
To Evaluate the Impact of Three Feeding Regimens on the Recovery of Children From Uncomplicated Severe Acute Malnutrition (SAM) in India and to Use the Evidence to Inform National Policy
2 other identifiers
interventional
911
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 8, 2015
June 1, 2015
2.5 years
October 8, 2012
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery by 16 weeks after enrollment (defined as achieving weight for height greater than or equal to -2 SD and absence of oedema of both feet)
Weekly till recovery or 16 weeks after enrollment, whichever is earlier
Secondary Outcomes (9)
Mortality and hospitalizations
Weekly till 16 weeks or recovery and at end of sustenance phase
Rate of weight gain (grams/kg body wt/day)
From enrollment till recovery or 16 weeks whichever is earlier
Time required to reach recovery
From enrollment till recovery or 16 weeks whichever is earlier
Íncidence and prevalence of diarrhea, ARI and fever during treatment phase
From enrollment till recovery or 16 weeks whichever is earlier
Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet
At the end of sustenance phase
- +4 more secondary outcomes
Study Arms (3)
RUTF-Centrally produced
EXPERIMENTALReady to Use Therapeutic Food-Centrally produced by an Indian company
RUTF-Locally produced
EXPERIMENTALReady to Use Therapeutic Food-Locally produced by the study team at each study site
High energy and micronutrient rich foods
ACTIVE COMPARATORHigh energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
Interventions
Ready to Use Therapeutic Food-Centrally produced by an Indian company.
Ready to Use Therapeutic Food prepared by the study team
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
Eligibility Criteria
You may qualify if:
- Age 6 to 59 months
- SAM, defined as Weight for height less than -3 SD of WHO standard or oedema of both feet or both.
You may not qualify if:
- Complicated SAM defined as child with SAM having signs of severe illness requiring hospitalization
- Known allergy to animal milk or peanuts
- Likely to leave the study area permanently in the next 16 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Society for Applied Studieslead
- Arthcollaborator
- Christian Medical College, Vellore, Indiacollaborator
- World Health Organizationcollaborator
Study Sites (3)
Centre for Health Research and Development, Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110062, India
Action Research & Training for Health (ARTH)
Udaipur, Rajasthan, 313004, India
Christian Medical College
Vellore, Tamil Nadu, 632002, India
Related Publications (2)
Garg CC, Mazumder S, Taneja S, Shekhar M, Mohan SB, Bose A, Iyengar SD, Bahl R, Martines J, Bhandari N. Costing of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition from a randomised trial in India. BMJ Glob Health. 2018 Mar 6;3(2):e000702. doi: 10.1136/bmjgh-2017-000702. eCollection 2018.
PMID: 29527358DERIVEDBhandari N, Mohan SB, Bose A, Iyengar SD, Taneja S, Mazumder S, Pricilla RA, Iyengar K, Sachdev HS, Mohan VR, Suhalka V, Yoshida S, Martines J, Bahl R. Efficacy of three feeding regimens for home-based management of children with uncomplicated severe acute malnutrition: a randomised trial in India. BMJ Glob Health. 2016 Dec 30;1(4):e000144. doi: 10.1136/bmjgh-2016-000144. eCollection 2016.
PMID: 28588982DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nita Bhandari, MD, PhD
Centre for Health Research and Development, Society for Applied Studies
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 8, 2012
First Posted
October 12, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 8, 2015
Record last verified: 2015-06