Soy-Ready to Use Therapeutic Food (RUTF) in Severely Malnourished Children
Condition: Severe Acute Malnutrition; Severe Wasting; Community Based Nutritional Management
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional
      edema is an important cause of death in children globally including Bangladesh. The death
      rate among children hospitalized for SAM is still high. Severe malnutrition in children can
      be successfully treated by using WHO guidelines with or without minor modification. Since the
      Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the
      treatment of children with SAM has gained ground, and huge amounts of RUTF are used
      particularly in African countries. RUTFs are an energy-dense lipid paste enriched with
      vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk
      powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%.
      Although the CTC model promises treatment of SAM at a considerably lower cost than the
      previous inpatient model, the cost of RUTF is still considered a significant barrier to
      universal roll-out of SAM treatment and has made CTC implementation too expensive in many
      high-need countries.

      The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of
      raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy
      protein has a cost per kg protein that normally is below that of skim or whole milk powder,
      and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high
      quality, complete protein that meets the daily protein requirements of growing children and
      adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that
      has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of
      1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed
      as the sole protein source at minimum recommended intake levels.

      To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of
      the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked
      intervention trial 300 SAM children aged 6 to 59 months after completion of their
      stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will
      randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving
      -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at
      the outpatient department of this Dhaka Hospital of icddr,b.
    


Intervention name(s): Soy-based RUTF (in double blind design)
Intervention type(s): Dietary Supplement
Intervention description(s): Soy-based RUTF will be given in double blind manner
Other intervention name(s): Soy-based RUTF is the intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Severe acute malnutrition; Ready to use therapeutic food; Soy protein; Community based management; Efficacy; Management of Children with SAM in Bangladesh