Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants (LCNI-5)
Malnutrition, Stunting, Developmental Delay
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring Infant, Sub-Saharan Africa, Complementary feeding, Fortified spread, Lipid-based nutrient supplement, Malnutrition, Stunting, Growth, Morbidity, Development, Haemoglobin
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent from at least one guardian
- Age 5.50 months to 6.49 months
- Availability during the period of the study.
- Permanent resident of Lungwena Health Centre or Malindi Hospital catchment area
Exclusion Criteria:
- Existing or imminent severe stunting (HAZ < -2.8)
- Weight for length (WFH) < 80% of the reference median or presence of oedema
- Severe illness warranting hospital referral.
- History of allergy towards peanut
- History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
- Concurrent participation in any other clinical trial
Sites / Locations
- College of Medicine, University of Malawi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
ST-DI
FSm
FSs
LP
Standard treatment - delayed intervention. Counselling on complementary feeding + Vitamin A (200,000 IU) every 6 months until 36 months + 1 kg maize / soy flour 2-weekly (71 g / day) between 18 and 30 months of age.
Fortified Spread (milk). 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.
Counselling + 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.
Likuni Phala. 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.