The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers (NCT03411590) | Clinical Trial Compass
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The Effect of Fortified Growing-up Milk on Growth and Micronutrient Status of Nigerian Toddlers
150 participantsStarted 2018-02-05
Plain-language summary
It is well known than an important part of Nigerian children from the lower social economic class have nutrient deficiencies. Fortified products, such as growing up milks (GUM), may play an important role in reducing the risk and incidence of nutrient deficiencies. However, affordability of GUM is an issue.
In this project the effects are studied of different daily intakes of GUM on iron status, growth, several other nutrient status parameters in blood and urine, cognitive development, and the intestinal microbiome in Nigerian toddlers 1-3 years of age.
The project is a collaboration with the department of Paediatrics and Child health of the Lagos State University College of Medicine in Lagos. The design is based on a three-arm, open (partly blind: statistics, biochemical analyses), randomized intervention trial. Recruitment will take place in Ijora-Badia community in Apapa-Iganmu Local Council Development Area (LCDA) in Lagos. The three groups will be given a multi-micronutrient fortified growing-up milk (PEAK), in amounts of 200, 400 or 600 ml per day during a period of 6 months. Primary objective of this study is to reduce iron deficiency anemia. Based on this objective, in total 150 children have to be included in this study.
Who can participate
Age range1 Year – 3 Years
SexALL
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Inclusion criteria
✓. Normal term birth (caesarean section excluded)
✓. Boys and girls in the age range of 12 to 36 months at enrolment
✓. Apparently healthy at screening (assessed with the use of a medical history record)
✓. Hb ≥70 g/L and ≤109 g/L, according to WHO guidelines 27
✓. Mild to moderate acute malnutrition (i.e. HAZ, WAZ \<-1 SD and \> -3 SD)
✓. Parents and/or legal guardians are residents of Oshodi LGA
✓. Parents and/or legal guardians do not plan to migrate during the study
✓. Written informed consent from parents and/or legal guardians
Exclusion criteria
✕. Severe anaemia (Hb\<70 g/L) or normal Hb (Hb≥110 g/L)
✕. Severe acute malnutrition (HAZ, WAZ \<-3 SD) requiring hospitalization