Effects of Three Feeding Regimens on Recovery of Uncomplicated Severely Acute Malnourished Children
Condition: Uncomplicated Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

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 description: 
      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 capital region, rural (predominantly tribal) Rajasthan, rural and
      urban Tamil Nadu. Field workers will survey the study area to measure mid-upper arm
      circumference (MUAC) in children 6 to 59 months of age and refer children with MUAC less than
      13 cm to a study clinic. At the study clinic, anthropometric measurements will be taken and
      children with weight for height less than -3 SD of the WHO standards or oedema of both feet
      will be offered participation in the study.

      Intervention and Comparison Regimes for Home Management of SAM

        -  Children randomized to the first intervention arm (Arm 1) will receive a centrally
           produced RUTF.

        -  Children randomized to the second intervention arm (Arm 2) will receive a locally
           produced RUTF.

        -  Children randomized to the comparison group (Arm 3) will receive augmented Home-Prepared
           Foods.

      The amount of food advised for each child in all the 3 study arms are calculated to provide
      175cal/kg body weight per day. These foods will be given to children from the time of
      enrollment until recovery (but not beyond 16 weeks). Caregivers of all enrolled children will
      receive counseling on frequency of feeding, amounts to be fed, encouraging children to
      continue breastfeeding and good hygiene practices. Additional support through a volunteer
      from the community will be provided to mothers who give consent, to assist in feeding the
      child.

      Management Phases: The management will be in two phases:

      Treatment Phase: From enrolment until recovery or 16 weeks (whichever is earlier), enrolled
      children will be provided the foods according to the study group they are randomized to, and
      counselled on their use.

      Sustenance Phase: After completion of the treatment phase, children in all arms will be
      referred to the closest Anganwadi centre from where he/she will access supplementary foods
      given to children as a part of the ICDS strategy. The sustenance phase will last for 16 weeks
      after end of treatment phase.

      Outcomes: A trained and standardized team of field workers will conduct weekly anthropometric
      measurements and also record morbidity, hospitalizations and deaths from enrolment, weekly
      till recovery or 16 weeks whichever is earlier. In addition, mortality and hospitalization
      data will be collected at 16 weeks post treatment phase.

      The primary outcome will be recovery by 16 weeks after enrollment (defined as achieving
      weight for height greater than or equal to -2 SD and absence of oedema).

      Secondary outcomes will include:

        -  To compare the weight gain (in grams/kg body weight/day) from enrolment till recovery,
           or till 16 weeks in those who do not attain recovery, at 16 weeks after recovery.

        -  To compare the time required to reach recovery (in weeks).

        -  To determine the incidence and prevalence of diarrhea, ARI and fever during the
           treatment phase

        -  To compare the mortality and hospitalizations during the treatment phase, 16 weeks after
           recovery

        -  To compare the perceptions of families, health care providers and ICDS functionaries
           regarding feasibility of use of the feeding regimens in a sub sample from enrolment tom
           completion of treatment phase

        -  To ascertain factors which affect recovery, at 16 weeks post enrolment in those who do
           not recover.

        -  To compare the perceptions of families regarding Anganwadi centre experience at the end
           of sustenance phase.

        -  To compare the proportion of children with weight for height greater than or equal to -2
           SD and absence of oedema feet at 16 weeks after recovery (or 32 weeks after enrolment
           for those who do not recover)

        -  To document the costs of implementing the feeding regimens till end of treatment phase.

      This will include:

        1. Estimation of costs of human resource and other inputs

        2. Estimation of household costs

        3. Costs per week per child estimated based on total costs and covered population

      The project has been approved by the National Research Alliance for SAM constituted by the
      Department of Health and Family Welfare, Department of Health Research and Department of
      Biotechnology. It will be coordinated by Centre for Health Research and Development-Society
      for Applied Studies. WHO will provide technical support and monitoring for the study
      implementation as a response to a request from the Alliance. Oversight to the study will be
      provided by a Technical Advisory group constituted by the Alliance and a Data Safety
      Monitoring Board. Clearances have been sought from the state governments of Delhi, Rajasthan
      and Tamil Nadu.
    

Intervention name(s): Ready to Use Therapeutic Food-Centrally produced; Ready to Use Therapeutic Food-Locally produced; High energy and micronutrient rich foods
Intervention type(s): Other; Other; Other
Intervention description(s): 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
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment; severe acute malnutrition