Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the hypothesis that infants receiving fortified spread as a complementary
      food for one year grow better and do not become malnourished as often as infants who are
      provided with maize-soy flour for complementary porridge.
    

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 in Mangochi District, southern Malawi. In the
      present study the investigators will test the efficacy in growth promotion and other health
      benefits of this product when provided as a complementary food to infants between 6 and 18
      months of age.

      The study will be conducted in Lungwena area, Mangochi District, rural Malawi. A total of 180
      6-month old infants will be enrolled and randomised to three groups receiving different daily
      food supplements for 12 months. Children in group-one (control group) will receive 75g of
      maize/soy flour daily. Children in group-two will receive 25g RUTF daily and children in
      group-three will receive 50g RUTF daily for a period of 12 months. The food supplements will
      be delivered to the participant's home at weekly intervals.

      All children will undergo medical and anthropometric examinations at 4-monthly intervals and
      disease symptoms monitoring every week. Dietary intake assessments will be conducted at 12
      and 15 months of age. A random sample of 36 children will undergo breast milk intake
      assessments before the start of food supplementation and during food supplementation. A blood
      sample will be collected at the beginning and end of the study to measure blood haemoglobin
      and serum ferritin concentrations and test human immunodeficiency virus [HIV] (at 6 and 18
      months).

      The impact of the dietary interventions will be primarily assessed by comparing weight gain
      in the three intervention groups. Secondary outcomes include length gain, incidence of
      moderate underweight, stunting and wasting, cognitive and motor development at the end of
      trial and changes in blood haemoglobin and serum ferritin concentration. The study will also
      produce descriptive data on morbidity and intake of breast milk and other foods during the
      intervention.
    

Intervention name(s): fortified spread (RUTF); maize and soy flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Infant; Sub-Saharan Africa; Complementary feeding; Malnutrition; Growth; Fortified spread; Haemoglobin