Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the hypothesis that moderately underweight but not severely wasted
      6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for
      12 weeks grow better during the supplementation than infants who do not get any food
      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 micronutrient fortified spread, FS, 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, but not wasted, infants (defined as WAZ <-2,
      WHM=>80%) between 6 and 18 months of age.

      The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 291
      6-15 -month old infants will be enrolled and randomised to three groups receiving different
      daily food supplements for 12 weeks. Children in group one (control group) will not receive
      any supplementation, children in group two will receive 1200 g FS 4-weekly (43 g / day) and
      children in group 3 will received 2000 g of fortified maize/soy flour weekly (71 g / day).
      Participant´s guardians will collect the food supplements from a local health centre at
      4-weekly intervals.

      All children will undergo medical and anthropometric examinations at the beginning and end of
      the 12-week follow-up period. Dietary intake assessments will be conducted at 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 concentration.

      The impact of the dietary interventions will be primarily assessed by comparing weight gain
      in the three intervention groups. Secondary outcomes include length gain and changes in blood
      haemoglobin concentration. The study will also produce descriptive data on intake of foods
      during the intervention.
    

Intervention name(s): Food supplement: fortified spread; Food supplement: maize-soy flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Provision of fortified spread; Provision of corn-soy blend (maize-soy flour)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant; Malnutrition; Sub-Saharan Africa; Treatment; Growth; Haemoglobin; Fortified spread; Food supplement