Efficacy 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-soy 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 189
      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 300 g FS weekly (43 g / day) and
      children in group 3 will received 500 g of fortified maize/soy flour weekly (71 g / day). The
      food supplements will be delivered to the participant's home at 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 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.

      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 and serum ferritin concentration. The study will also produce descriptive data on
      morbidity and intake of foods during the intervention.
    

Intervention name(s): No food supplement; Food supplement: fortified spread; Food supplement: maize-soy flour
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Infant; Malnutrition; Sub-Saharan Africa; Treatment; Growth; Haemoglobin; Fortified spread; Food supplement