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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,920
* 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
University of Malawi, College of Medicine
Mangochi, Malawi
Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age
Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Incidence of serious adverse events during the study period
Time frame: 12 months after enrollment (age 18 months)
Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores
Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Incidence of stunting, underweight, and wasting
Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)
Prevalence of reduced appetite
Time frame: Daily assessment during 12 month supplementation
Energy intake from complementary foods
Time frame: 3 and 9 months after enrollment (age 9 and 15 months)
Incidence of laboratory-confirmed malaria infection
Time frame: 12 months after enrollment (age 18 months)
Incidence of caregiver-reported morbidity
Time frame: Daily assessment during 12 month supplementation
Immune function (measured by humoral immunity towards measles vaccination)
Time frame: 12 months after enrollment (age 18 months)
Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine
Time frame: 12 months after enrollment (age 18 months)
Proportion with anaemia at 18 months of age
Time frame: 12 months after enrollment (age 18 months)
Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)
Time frame: 12 months after enrollment (age 18 months)
Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months)
Time frame: Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months
Incidence of all adverse events during the study period
Time frame: 12 months after enrollment (age 18 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.