Malnutrition Clinical Trial
Official title:
Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.
Objective: To acquire the local scientific evidence, to evaluate the effects of
micronutrient Sprinkles™ powder, both the nutritional status and haematological values in
the vulnerable preschool population, to corroborate the reported benefits of the experiences
in other countries.
Question: Will it improve the nutritional status and hematological levels after the home
fortification with Sprinkles in children of two child care centres in the city of Medellin,
in 2013?
Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators
will be better in the intervention group with Sprinkles, compared with the placebo group.
Design: Randomized clinical trial, triple-blind and placebo-controlled.
Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or
with severe malnourished, full-time assistants to two children's centres that have the same
alimentation menu.
Intervention: The daily diet will be supplemented with sprinkles in one of the children's
centres and will be compared anthropometric and hematological values before and after with a
group receiving the same diet with placebo.
Outcome measures: Nutritional status (anthropometric measures) and haematological values
(hemoglobin, ferritin, transferrin and folate).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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