Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children
Condition: Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      In this clinical non-inferiority trial, two foods will be compared for the treatment of SAM,
      testing the hypothesis that the difference in recovery rates and growth between the two test
      groups will be no greater than 5 percent.
    

Detailed description: 
      This will be a randomised, triple-blinded, controlled clinical non-inferiority trial
      assessing the treatment of SAM with one of two therapeutic foods until the child is recovered
      or for a period of up to 12 weeks.

      Subjects will be recruited from rural health clinics in the Western Rural Region and Pujehun
      District of Sierra Leone, due to the limited accessibility of treatment programs in this
      area; investigators believe a clinical trial in this district will be beneficial.

      Sierra Leonean children aged 6-59 months with uncomplicated SAM (with WHZ < -3, MUAC of <11.5
      cm, or bipedal edema) will be recruited at health clinics in the Western Rural Region and
      Pujehun District. A total of 1,300 children will be enrolled for a total sample size of 1,262
      (631 per treatment) from 30 PHU centers, to detect a 5% difference in recovery rates between
      any two foods, with 95% sensitivity and 80% power, assuming that the standard recovery rate
      is 85% and a binary non-inferiority test.

      After screening and enrolment, each child's participation will last up to 12 weeks. If a
      child recovers before the end of the 12-week period, a child's WHZ reaches and stays above -2
      for two consecutive visits without edema, the child will graduate from the study. No study
      food products will be given to children after 12 weeks of participation; those who have not
      recovered will be taken for inpatient treatment. Children will enter the study on a rolling
      enrolment basis and will continue to be enrolled until 1,300 children complete the study.

      Random allocation of food intervention will be conducted by nurses who will have the
      caregiver draw opaque envelopes containing one of 4 colours. Caretakers chose a sealed
      envelope that contains 1 of 4 colours: 2 of these colours correspond to the control food and
      2 to the experimental food. The colour will be recorded separately from the child's clinical
      measurements and researchers involved in the randomization process do not know which colour
      corresponds to which food corresponding to one of the therapeutic foods. The code will be
      accessible only to the food distribution personnel, who do not assess participant outcomes or
      eligibility. Investigators performing clinical assessments and caretakers will be blinded to
      the child's assigned food group.

      A sub-set of participants in the main study will undergo eye-tracking testing to evaluate
      neurocognitive function and recovery in children with severe acute malnutrition after
      receiving therapeutic food.
    

Intervention name(s): Alternative RUTF; Standard RUTF
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier.; Standard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: severe acute malnutrition, SAM