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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

India accounts for over half the global burden of severe acute malnutrition (SAM) in the world. While it is important to accelerate efforts to prevent SAM, effective management of children suffering from it is critical for reducing child mortality and achieving MDG1 and MDG4.

Available evidence mostly from studies in Africa suggest that home based management of uncomplicated SAM with Ready to Use Therapeutic Foods (RUTF) is at least as efficacious as facility-based management and that locally produced RUTF is as efficacious as centrally produced RUTF. More evidence on efficacy and effectiveness of home based management using RUTF is needed to decide if this intervention offers substantial advantages over home-prepared foods in the Indian settings. Additionally, there is a demand to generate evidence of efficacy of locally produced RUTF as compared to that of centrally produced RUTF. These issues can only be resolved through a well designed randomized controlled trial.

This project therefore aims to assess the efficacy of three options under consideration in India for home management of 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 the comparison group.

Participants: The study will be conducted in three sites - urban slums and resettlement colonies in the national
Sponsor: Society for Applied Studies

Current Primary Outcome: 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 ]

Original Primary Outcome: Recovery by 8 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: 8 weeks after enrollment ]

Current Secondary Outcome:

  • Mortality and hospitalizations [ Time Frame: Weekly till 16 weeks or recovery and at end of sustenance phase ]
  • Rate of weight gain (grams/kg body wt/day) [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ]
  • Time required to reach recovery [ Time Frame: From enrollment till recovery or 16 weeks whichever is earlier ]
  • Íncidence and prevalence of diarrhea, ARI and fever during treatment phase [ Time Frame: 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 [ Time Frame: At the end of sustenance phase ]
  • Cost of three feeding regimens [ Time Frame: Enrollment to end of treatment phase ]
  • 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 ]
  • Factors which affect recovery [ Time Frame: At 16 weeks post enrolment in those that have not recovered ]
  • Perception of families regarding anganwadi centre experiences at the end of sustenance phase [ Time Frame: from end of treatment phase to end of sustanence phase ]


Original Secondary Outcome:

  • Mortality [ Time Frame: 4, 8 and 26 weeks after enrollment ]
  • Rate of weight gain (grams/kg body wt/day) [ Time Frame: From enrollment till recovery or 8 weeks whichever is earlier ]
  • Time required to reach recovery [ Time Frame: From enrollment till recovery or 8 weeks whichever is earlier ]
  • Proportion of children who have diarrhea [ Time Frame: 4 weeks after enrollment ]
  • Proportion of children with weight for height greater than or equal to -2 SD and absence of oedema of feet [ Time Frame: 18 weeks after recovery and 26 weeks after enrollment ]
  • Cost of three feeding regimens [ Time Frame: Enrollment to end study ]
  • 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 ]
  • Hospitalizations [ Time Frame: 4, 8 and 26 weeks after enrollment ]


Information By: Society for Applied Studies

Dates:
Date Received: October 8, 2012
Date Started: October 2012
Date Completion:
Last Updated: June 4, 2015
Last Verified: June 2015