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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Society for Applied Studies
Sponsor:
Collaborators:
Action Research and Training for Health (ARTH), Udaipur
Christian Medical College, Vellore, India
World Health Organization
Information provided by (Responsible Party):
NBhandari, Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT01705769
First received: October 8, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 765 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.


Condition Intervention
Uncomplicated Severe Acute Malnutrition
Other: Ready to Use Therapeutic Food-Centrally produced
Other: Ready to Use Therapeutic Food-Locally produced
Other: High energy and micronutrient rich foods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • 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) [ Time Frame: Weekly till recovery or 16 weeks after enrollment, whichever is earlier ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality and hospitalizations [ Time Frame: Weekly till 16 weeks or recovery and at end of sustenance phase ] [ Designated as safety issue: No ]
  • Rate of weight gain (grams/kg body wt/day) [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ] [ Designated as safety issue: No ]
  • Time required to reach recovery [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ] [ Designated as safety issue: No ]
  • Íncidence and prevalence of diarrhea, ARI and fever during treatment phase [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ] [ Designated as safety issue: No ]
  • Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet [ Time Frame: At the end of sustenance phase ] [ Designated as safety issue: No ]
  • Cost of three feeding regimens [ Time Frame: Enrollment to end of treatment phase ] [ Designated as safety issue: No ]
  • Feedback from families, health care providers and ICDS functionaries about the feeding regimens regarding perceptions and feasibility of use [ Time Frame: Enrollment to end study ] [ Designated as safety issue: No ]
  • Factors which affect recovery [ Time Frame: At 16 weeks post enrolment in those that have not recovered ] [ Designated as safety issue: No ]

Estimated Enrollment: 765
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RUTF-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company
Other: Ready to Use Therapeutic Food-Centrally produced
Ready to Use Therapeutic Food-Centrally produced by an Indian company.
Experimental: RUTF-Locally produced
Ready to Use Therapeutic Food-Locally produced by the study team at each study site
Other: Ready to Use Therapeutic Food-Locally produced
Ready to Use Therapeutic Food prepared by the study team
Active Comparator: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
Other: High energy and micronutrient rich foods
High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705769

Contacts
Contact: Nita Bhandari, MD, PhD 00911146043751 ext 202 CHRD@sas.org.in

Locations
India
Centre for Health Research and Development, Society for Applied Studies Recruiting
New Delhi, Delhi, India, 110062
Contact: Sanjana B Mohan    011 46043751-55    CHRD@sas.org.in   
Principal Investigator: Sanjana M Mohan         
Action Research & Training for Health (ARTH) Recruiting
Udaipur, Rajasthan, India, 313004
Contact: Sharad Iyengar    +91-294-2451033    sdiyengar@gmail.com   
Principal Investigator: Sharad Iyengar         
Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632002
Contact: Anuradha Bose    +91-416-2284207    abose@cmcvellore.ac.in   
Principal Investigator: Anuradha Bose         
Sponsors and Collaborators
Society for Applied Studies
Action Research and Training for Health (ARTH), Udaipur
Christian Medical College, Vellore, India
World Health Organization
Investigators
Principal Investigator: Nita Bhandari, MD, PhD Centre for Health Research and Development, Society for Applied Studies
  More Information

No publications provided

Responsible Party: NBhandari, Director, Society for Applied Studies
ClinicalTrials.gov Identifier: NCT01705769     History of Changes
Other Study ID Numbers: RPC538, CTRI/2012/10/003054
Study First Received: October 8, 2012
Last Updated: June 18, 2013
Health Authority: India: Ministry of Science and Technology
Switzerland: World Health Organization
India: National Research Alliance for Severe Acute Malnutrition, Government of India

Keywords provided by Society for Applied Studies:
treatment
severe acute malnutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014