To assess zinc-related biochemical and functional responses among young Burkinabe children with a presumed high risk of zinc deficiency who receive micronutrient products containing different amounts of zinc, provided with or between meals.
Young healthy children will be identified by periodic consensus in the study area. 3200 infants meeting a set of eligibility criteria will be randomly assigned to receive lipid-based nutrient supplements (LNS) with different amounts of zinc and a placebo or zinc supplement from 9 to 18 months of age. The families will receive the respective supplement at weekly intervals and the participants undergo a morbidity evaluation weekly, anthropometric evaluation at 9, 12, 15 and 18 months and laboratory analyses at enrollment and at 18 months of age. Growth outcomes will be analyzed during the two-year follow up at 24, 30, 36 and 42 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,220
Daily consumption of 20 g LNS containing 5 mg of zinc and daily placebo supplement
Daily consumption of 20 g LNS containing 10 mg of zinc and daily placebo supplement
20 g of LNS containing 0 mg of zinc and a daily placebo supplement
Institut de Recherche en Sciences de la Sante
Bobo-Dioulasso, Burkina Faso
Change in length and length-for-age Z-score
Time frame: 9 to 18 mo of age
Change in weight and weight-for-age Z-score
Time frame: 9 to 18 mo of age
Incidence of diarrhea and laboratory-confirmed malaria infection
Time frame: 9 to 18 mo of age
Change in plasma zinc concentration
Time frame: 9 to 18 mo of age
Change in body composition
Time frame: 9 to 18 mo of age
Change in head circumference and mid-upper arm circumference
Time frame: 9 to 18 mo of age
Change in stunting, underweight, and wasting
Time frame: 9 to 18 mo of age
Change in hemoglobin, iron, vitamin A and iodine status
Time frame: 9 to 18 mo of age
Incidence of acute lower respiratory infection (ALRI)
Time frame: 9 to 18 mo of age
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Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc