Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM
Condition: Severe Acute Malnutrition; Kwashiorkor; Nutritional Edema; Marasmus
MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Interventional

Summary: 
      Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a
      weight-for-height Z-score more than three standard deviations (SD) below the median based on
      the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference
      (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema,
      mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and
      rapid progression to mortality characterize a state commonly coined as "complicated SAM".
      Kwashiorkor is one of the forms of complicated SAM commonly distinguished by the unmistakable
      presence of bipedal edema. SAM results in high mortality rates of up to half a million child
      deaths annually. Undernourished children are at higher risk of mortality ranging from three
      times more risk among children with moderate malnutrition to 10-times in SAM children
      compared to well-nourished children. Children with complicated SAM require inpatient
      treatment in specialized centers.

      The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in
      Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than
      international standards; and adverse events and mortality remain strikingly high.

      Our main objective is to assess the underlying risk factors affecting the effectiveness of
      the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of
      age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo
      Dioulasso, Burkina Faso.

      The specific objective is to assess the effectiveness of alternative dietary regimens during
      the stabilization phase on well-specified clinical and biochemical outcomes in children with
      complicated SAM. Dietary regimens differ by their carbohydrate profile and content, and by
      their different micronutrient composition including vitamin A, iron and zinc.
    

Detailed description: 
      Severe acute malnutrition (SAM), defined as severe wasting [weight-to-height Z-score < -3
      standard deviations (SD), based on the WHO Child Growth Standards] and / or the presence of
      nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that
      requires urgent attention and appropriate management to reduce mortality and promote recovery
      among children. Management of SAM children without complications is provided at the community
      level. Hospitalization in specialized care centers is necessary for SAM children with
      complications. SAM children with comorbidities have a greater risk of mortality and treatment
      failure. Our knowledge of the specific adequate nutritional needs of SAM is limited.

      For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in
      protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with
      ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using
      as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a
      therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard
      therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea).

      The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the
      Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM
      children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM
      with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death.
      Although the recovery rate is higher than international standards (greater than 75%), the
      mortality rate remains higher than the recommended 3% by international standards; in addition
      to the challenges that are faced locally in maintaining high standards of care. At the CREN,
      we observed that some SAM children with complications can have severe diarrhea and vomiting
      after taking F75 (first phase of the nutritional treatment). It was also observed that other
      SAM children with edema, whose edema resolved in the first phase of treatment under F75,
      redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to
      the WHO 2013 protocol.

      The second objective of the study is to assess the risk factors affecting the response to
      dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for
      treatment during the nutritional rehabilitation.

      Problematic It was observed at the Refeeding Center (CREN) of the Sourô Sanou University
      Hospital (CHUSS) in Bobo Dioulasso, that SAM children with complications show during their
      treatment, signs of intolerance to F75 (diarrhea , vomiting). The pathophysiology of diarrhea
      in SAM involves several theories including that of lactose intolerance, and that of
      alteration of the intestinal microbiota.

      The study aims to assess the effectiveness of diet regimens [standard F75, or alternative F75
      + mineral vitamin complex (CMV), or alternative F75 without CMV] during the stabilization
      phase from both a clinical and biochemical aspects in children with complicated SAM. Diets
      differ in their profile and carbohydrate content, and in their different micronutrient
      compositions, including vitamin A, iron and zinc.

      Our hypothesis is that the F75 alternative during the stabilization phase (the first phase)
      of complicated SAM children is associated with better compliance, less diarrhea and better
      outcomes than the recommended F75 formulation; and that children treated correctly with the
      F75 alternative containing CMV will perform better than the other two groups of children
      treated with F75 or the F75 alternative without CMV.

      This will be an open, randomized controlled trial aimed at testing the effectiveness of three
      therapeutic diet regimens during the first phase of hospital management of children with
      complicated SAM admitted to CREN, Bobo Dioulasso.

      After obtaining informed consent from parents / guardians for the inclusion of the child, the
      child will be randomized and will receive their assigned treatment. In accordance with the
      2014 protocol for the management of SAM in Burkina Faso, an antibiotic will be given as part
      of the systematic treatment of complicated SAM, and other medical treatments depending on the
      associated complication. Deworming is provided also gratis, will be done only in children
      whose tests are positive for intestinal parasites and ONLY in the rehabilitation phase (the
      third phase of the treatment) as per the National Protocol for the management of complicated
      SAM. The dietetic treatment will be given by the nurses every 2 hours on the first day; then
      if tolerance is good, every 3 hours the following days. No family meals during phase 1. But
      the baby can breastfeed. The observance and tolerance of the treatment will be noted by the
      nurses: amount of milk taken, refusal, vomiting, diarrhea, presence of a nasogastric tube.
      The quantities will be given according to the weight of the child, the presence or not of
      edema, in accordance with the national protocol.
    

Intervention name(s): Standard F75; Alternative F75 with CMV; Alternative F75 without CMV
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): F-75 contains 75 kcal and 0.9 g protein per 100 ml; Alternative F75 With CMV contains cereal flour, oil, sugar, powdered milk with complex mineral-vitamin (CMV); Alternative F75 without CMV contains cereal flour, oil, sugar, powdered milk without complex mineral vitamin (CMV).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be an open, randomized controlled trial aimed at testing the effectiveness of three therapeutic diet regimens during the first phase of hospital management of children with complicated SAM admitted to CREN, Bobo Dioulasso.
Children aged 6 to 59 months hospitalized in the pediatric department or other services of the Bobo Dioulassso CHUSS, and admitted to the CREN for complicated SAM (WHZ < -3 SD and/or MUAC < 115 mm and/or the presence of nutritional edema) will be randomly assigned to receive:
Standard F75;
Alternative F75 without CMV (mainly containing corn flour, sugar, powdered milk and oil); and
Alternative F75 with CMV (includes most minerals and vitamins like F75 and F100).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Severe acute malnutrition; Nutritional rehabilitation; F75; Stabilization phase; Therapeutic complex of vitamins and minerals (CMV); Kwashiorkor; Marasmus