Development and Field Testing of Ready-to-use-therapeutic Foods Made of Local Ingredients in Bangladesh for SAM Children
Condition: Severe Acute Malnutrition in Childhood
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Around 0.5 million under-five children are currently suffering from severe acute malnutrition
      (SAM) in Bangladesh and are at risk of death. Children with SAM and complications should be
      treated in a health care facility. It is imperative, however, to manage children with SAM but
      without any complications in the community. This requires a ready-to-use-therapeutic food
      (RUTF) that conforms to standard recommendations on its composition. The prototype RUTF is
      peanut based, made outside Bangladesh, and has to be imported. By developing a RUTF using
      local food ingredients, test it for acceptability and efficacy in the treatment of children
      with SAM, hopefully make the treatment of SAM cost-effective and sustainable.

      Hypothesis: Does the locally developed ready-to-use-therapeutic foods (RUTFs) demonstrate
      similar or better acceptability and efficacy in the treatment of children suffering from
      severe acute malnutrition (SAM) when compared to the prototype RUTF (Plumpynut)?
    

Detailed description: 
      Childhood malnutrition continues to be a significant public health problem in the world,
      especially in Asia. Acute malnutrition and more so, severe acute malnutrition (SAM) among
      children below five years of age remains a major embarrassment, and impediment to optimal
      human capital development in Asia. Without access to appropriate treatment, these SAM
      children are at high risk of death; there are only a few hospitals in Bangladesh and other
      developing countries with facilities for managing these children appropriately and their
      coverage is extremely low. In 2008, the Government of Bangladesh published National
      Guidelines for management of SAM at the facility level. However, these national guidelines
      have yet to become operationalized and there are very small exploratory initiatives that
      focus on community-based management of acute malnutrition (CMAM). Under the auspices of the
      Directorate General of Health Services, a 2007 national consensus meeting on the management
      of SAM resolved that CMAM along with scaling up facility-based management is essential for
      Bangladesh but that a local RUTF should be developed to ensure cost-effective and sustainable
      programs. Absence of a RUTF that is made of locally available food ingredients and hence,
      relatively inexpensive, is impeding the implementation of programs for community-based
      management of SAM in the country. The proposed project will develop new and improved recipes
      of RUTF based on established principles of dietetics and select at least two candidate RUTFs
      for treating SAM and testing their acceptability and efficacy. The experiments for
      development of RUTF will be done in ICDDR,B Food Processing Laboratory by the investigators.
      Experiments, including assessment of the composition of the local food ingredients and the
      presence of anti-nutrient factors, such as phytate, will be performed in the laboratories of
      Nutriset in France. Acceptability of the candidate RUTFs by the children as well as by the
      mothers will be assessed and compared among groups of children, who receive any new two RUTF
      products and the prototype RUTF (Plumpy'nut). For efficacy trial, the study population will
      be the children who will come to ICDDR,B hospital with SAM and complications. They will
      receive the standardized management during the acute/initial phase of treatment in the
      hospital. After completion of the initial treatment of associated medical complications an
      appetite test with the standard RUTF will be done. If the child passes the appetite test, the
      child will be enrolled in the study and subsequent alternate feeds of the child will be
      replaced with the assigned RUTF. The child will be further observed next day giving the total
      ration of the assigned RUTF and will be monitored for any possible adverse effects, e.g. skin
      rash, urticaria from food allergy, abdominal distension, pain abdomen, vomiting, diarrhea or
      any other significant change in clinical status. If there is no unwanted event and the child
      eats RUTF eagerly, then the child will be discharged from the hospital with RUTF ration for
      one week (7- 10 days' ration covering the weekends and any holidays). The RUTFs will be used
      in a partial double-blind manner. Complete blinding of the three RUTFs might not be possible
      because of distinctive smell of peanuts in proto type RUTF. Other two candidate RUTFs will be
      blinded. The code will be kept by the producer of the sachets (Nutriset) and Dr ASG Faruque,
      Senior Scientist, ICDDR'B, who will not be involved with the study. A team of ICDDR,B staff
      will be responsible for implementation of the study. All field personnel recruited will be
      full time for this study and will have prior experience in interview techniques, data
      collection, and assessment of nutritional status. Before starting field activities, an
      intensive 5-day training will be given to the supervisors and interviewers. The quality
      control team supported by investigator(s) will monitor the performance of field personnel
      through regular observation at the household level and regular checks of data for
      completeness. The quality control team will independently check the data collection. Errors
      detected will be corrected immediately in the field. The entire assignment including the
      report writing will be completed within 24 months after the IRB approval from ICDDR,B and
      signing of MOU between the UNICEF, Bangladesh, Nutriset and ICDDR,B.
    

Intervention name(s): RUTF-1; RUTF-2; Plumpynut
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Made from local food ingredients; Made from local food ingredients; Commercially made from peanut paste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment