Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the hypothesis that underweight 6-17-month old infants receiving fortified
      spread as a food supplement for 12 weeks grow better during the supplementation than infants
      who are provided with maize-soy flour supplement.
    

Detailed description: 
      Childhood undernutrition is very common in rural Malawi, like in many other countries in
      Sub-Saharan Africa. Usually, undernutrition develops between 6 and 24 months of age. By two
      years of age, 30-50% of all children in rural Malawi are undernourished, predisposing them to
      subsequent morbidity, developmental delay and mortality. Urgent interventions are needed but
      the magnitude of the problem precludes a hospital-based management strategy. Therefore,
      emphasis must be on prevention and early home-based rehabilitation of children with
      mild-to-moderate malnutrition. However, the options for community based approaches are not as
      developed as those for institutional management of undernutrition.

      The present study tests a recently developed nutrient -dense spread, ready-to use-
      therapeutic food (RUTF), which offers a potential solution to home based nutrition
      rehabilitation. The concept has previously been shown to work not only in therapeutic feeding
      of undernourished children in nutrition rehabilitation units in Malawi but also home based
      supplementation of undernourished children aged 42 to 60 months in Mangochi District,
      southern Malawi. In the present study the investigators will test the efficacy in growth
      promotion of this product when provided as a supplementary food to moderately underweight
      infants (defined as WAZ <-2) between 6 and 18 months of age.

      The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 176
      6-14 -month old infants will be enrolled and randomised to two groups receiving different
      daily food supplements for 12 weeks. Children in group one (control group) will receive 72g
      of fortified maize/soy flour and children in group 2 will receive 50g RUTF daily. The food
      supplements will be delivered to the participant's home at 3-weekly intervals.

      All children will undergo medical and anthropometric examinations at 6-weekly intervals and
      disease symptoms monitoring every week. Dietary intake assessments will be conducted at 3 and
      9 weeks after the onset of supplementation. A blood sample will be collected at the beginning
      and end of the study to measure blood haemoglobin and serum ferritin concentrations. At
      enrolment, children's HIV status will be screened with antibody-ELISA and confirmed with HIV
      PCR.

      The impact of the dietary interventions will be primarily assessed by comparing weight gain
      in the two intervention groups. Secondary outcomes include length gain, increase in tibial
      length and changes in blood haemoglobin and serum ferritin concentration. The study will also
      produce descriptive data on morbidity and intake of foods during the intervention.
    

Intervention name(s): Food supplement: fortified spread; Food supplement: maize and soy flour
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Infant; Malnutrition; Sub-Saharan Africa; Treatment; Growth; Haemoglobin; Fortified spread; Food supplement