Malnutrition
Conditions
Keywords
point-of-use fortification, zinc supplement, lipid-based nutrient supplement, zinc deficiency, micronutrient deficiency, anemia
Brief summary
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.
Detailed description
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.
Interventions
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
Daily 5 mg zinc supplement ant consumption of 20 g LNS containing 0 mg of zinc
Sponsors
Study design
Eligibility
Inclusion criteria
* 9.0 to 9.9 mo of age
Exclusion criteria
* severe anemia * severely malnourished * presence of bipedal oedema * severe illness * congenital abnormalities * chronic medical condition * known HIV infection of mother or infant * history of peanut allergy * history of anaphylaxis or serious allergic reaction to any substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body composition | 9 to 18 mo of age |
| Change in length and length-for-age Z-score | 9 to 18 mo of age |
| Change in weight and weight-for-age Z-score | 9 to 18 mo of age |
| Incidence of diarrhea and laboratory-confirmed malaria infection | 9 to 18 mo of age |
| Change in plasma zinc concentration | 9 to 18 mo of age |
Secondary
| Measure | Time frame |
|---|---|
| Change in stunting, underweight, and wasting | 9 to 18 mo of age |
| Change in hemoglobin, iron, vitamin A and iodine status | 9 to 18 mo of age |
| Incidence of acute lower respiratory infection (ALRI) | 9 to 18 mo of age |
| Change in head circumference and mid-upper arm circumference | 9 to 18 mo of age |
Countries
Burkina Faso