Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      1. RUTF would be more effective (quicker catch-up growth by promoting more tissue accrue
           resulting decrease stay in rehabilitation ward) in treating children with SAM during the
           rehabilitation phase than khichuri /halwa;

        2. RUTF would be acceptable to the children and their mothers/caregivers;

        3. Malnutrition is not caused solely by lack of food, but also by impaired utilization of
           the food that is ingested. The ability of the gut to absorb nutrients from the diet is
           associated with the host's 'human' genotype, the host's gut microbiota and its gene
           content (the microbiome).
    

Detailed description: 
      We propose to conduct a research study to compare the acceptability and efficacy of RUTF with
      that of the cereal-based diets in the management of hospitalised SAM children in Bangladesh.
      After completion of the initial acute phase treatment (for diarrhoea, lower respiratory tract
      infection/pneumonia, severe anaemia, fever, sepsis, electrolyte imbalance, and/or anorexia)
      in the Longer Stay Ward/ Special Care Ward of the Dhaka Hospital, the children will be
      transferred to the NRW according to the enrolment criteria. Once the children fulfil all the
      criteria for entry into the study and written consent to their participation is obtained from
      respective parents/guardian, they will be randomly allocated to: (i) the standard
      cereal-based foods, namely khichuri and halwa, or (ii) RUTF. Randomization will be done
      according to computer-generated random numbers using permuted blocks with block lengths of
      four and six. For understandable reasons, the dietary therapy can't be blinded. The assigned
      treatment packages will be kept in closed opaque envelopes until the same serial number is
      assigned to an enrolled child. Participating children will be discharged from NRW according
      to the new WHO growth standard (WHO, 2009), which explicit , at least after seven days stay
      completed there or until achieving a weight gain of 15% , for non-oedematous child. On the
      other hand for oedematous child after oedema free if WHZ is ≥-3; however if oedema free WHZ
      is <- 3 then the child will be discharge after achieving 15% weight gain. In both the groups,
      the acceptability of the allocated diet, both by the children and their respective
      mothers/caregivers, the rate of weight gain and anthropometric measurements, and adverse
      event will be systematically recorded for analyses. Khichuri/halwa group will be given diet
      as per standardized management protocol of NRW of the Dhaka Hospital. On the other hand,
      children allocated to RUTF will receive commercially available RUTF (Plumpy nut) in a total
      of 200 kcal/kg.day in a sequential manner (Plumpy nut will be offered ~ 125 kcal/kg in 1st 24
      hours, ~ 150 kcal/kg in 2nd 24 hours, then~200k cal/kg by the third day). We will also
      examine if the weight gain of the children is associated with increase in the lean body mass
      or in the body fat mass by assessing their body composition, Changes in body composition
      after dietary intervention in SAM children will be assessed by non-invasive technique using
      stable isotope tracer (deuterium oxide). For this, after collection of baseline urine and
      saliva samples a known quantity (5 gm) of deuterium oxide labelled water will be given to all
      study children. Enrichment of deuterium in body water will be measured to estimate total body
      water (TBW). Enrichment reaches a plateau after 3-5 hours. According to the recommendation
      from International Atomic Energy Agency (IAEA) field manual, two post-dose saliva samples
      will be collected at 3rd and 4th hours. The concentrations of deuterium in saliva samples
      will be measured with Fourier Transform Infrared Spectrometer (FTIR). The urine specimens
      will be analyzed using Isotope Ratio Mass Spectrometry (IRMS). From measured TBW we would
      estimate the fat free mass (FFM). Body fat mass (FM) is the difference between body weight
      and fat free mass. This procedure will be repeated in same sequence in all study children at
      the end of dietary intervention when the study child achieve discharge criteria. In addition
      to the above mentioned procedures, anthropometric measures such as mid-arm circumference,
      triceps skin fold thickness, arm fat area and arm muscle area would also be routinely
      recorded along with other morbidity data.

      We wish to leverage the ongoing scientific collaboration among University of Virginia, Center
      for Genome Sciences at Washington University School of Medicine, USA and ICDDR,B to gain
      insight into the influence of human genetic polymorphisms and gut microbiome on malnutrition,
      in order to provide a foundation for new treatment and prevention programs on a
      population-wide basis.
    

Intervention name(s): Plumpy Nut; Khichuri and Halwa
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): to RUTF will receive commercially available RUTF (Plumpy nut) in a total of 200 kcal/kg.day in a sequential manner (Plumpy nut will be offered ~ 125 kcal/kg in 1st 24 hours, ~ 150 kcal/kg in 2nd 24 hours, then~200k cal/kg by the third day).; Day 1: Milk suji, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day 125kcal/kg.day
Day 2: Milk suji, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day & khichuri 10gm/kg; 2 feed per day 150kcal/kg.day
Day 3: Milk suji 100, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day & khichuri 10gm/kg; 2 feed per day 175kcal/kg.day
Day 4: Milk suji 100, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 3 feed per day & khichuri 10gm/kg; 3 feed per day 200kcal/kg.day
Day 5 onward: Milk suji 100, 10ml/kg/ feed 6 hourly (4 feed per day) & halwa 20gm/kg; 3 feed per day & khichuri 20gm/kg; 3 feed per day 200kcal/kg.day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: RUTF; Severe Acute Malnutrition; Children; Body composition; Microbiota; Short Chain Fatty Acid; Acceptability of RUTF; Edema free 15 percent weight gain; Changes in body composition; Gut microbiota; Genome wide association