Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants
Condition: Malnutrition; Stunting; Developmental Delay
MeSH terms: Malnutrition; Growth Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests the hypothesis that infants receiving milk-powder containing fortified
      spread (lipid-based nutrient supplement) as a complementary food for one year have lower
      incidence of severe stunting (poor length gain) than infants who are provided with no extra
      food supplements or maize-soy flour for complementary porridge.
    

Detailed description: 
      Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in
      Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear
      growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily
      complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may
      markedly reduce the incidence of severe stunting before the age of 18 months. In the present
      study the investigators will more carefully analyze the efficacy in linear 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. Six-month old
      healthy infants are identified through community surveys in the study area. 840 infants
      meeting set criteria are randomized into receiving the following intervention between 6 and
      18 months of age: 1) standard treatment ie no extra food supplements (but dietary
      supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard"
      fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread
      with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala,
      LP). The families receive the food supplements at 2-weekly intervals and the participants
      undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week
      intervals. Outcome analyses are done at 18 and at 36 months of age.

      The impact of the dietary interventions will be primarily assessed by comparing the incidence
      of severe stunting in the four study groups. Secondary outcomes include a number of
      anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The
      study will also produce descriptive data on possible mechanisms for growth failure among the
      trial subjects.
    

Intervention name(s): Milk-containing fortified spread; Soy-containing fortified spread; Maize-soy flour
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.; Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.; Counseling + Vitamin A as for ST_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infant; Sub-Saharan Africa; Complementary feeding; Fortified spread; Lipid-based nutrient supplement; Malnutrition; Stunting; Growth; Morbidity; Development; Haemoglobin