Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have
      been associated with improved growth and development outcomes among infants in Ghana and
      Malawi. Modified versions of such supplements have been developed to improve their nutrient
      density and quality and to lower their costs. Such modified products have proven acceptable
      to infants and their guardians in Malawi and Ghana. In the present trial, the investigator
      aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the
      investigators will test a hypothesis that LNS that does not contain milk promotes growth as
      well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month
      old infants in rural Malawi.
    

Detailed description: 
      Six-month old healthy infants are identified through community surveys in the study area.
      1920 infants meeting set criteria are randomised into receiving the following intervention
      between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements,
      with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing
      LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS
      (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS
      (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the
      participants undergo a morbidity evaluation weekly, a limited development assessment at
      4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses
      at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of
      age.
    

Intervention name(s): Lipid-based nutrient supplement, 10gM; Lipid-based nutrient supplement, 20gM; Lipid-based Nutrient Supplement, 20gNoM; Lipid-based nutrient supplement, 40gM; Lipid-based Nutrient Supplement, 40gNoM; Maize-soy flour
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring; 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring; 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring; 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring; 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring; No food supplement during the primary trial period (6 to 18 months of age)
1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Stunting; Growth failure; Malnutrition; Lipid based nutrient supplement; LNS; Prevention; Malawi; Sub-Saharan Africa; Dietary supplementation; Efficacy