NCT01917032

Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

Effect of Home-fortification With Micronutrient Powder Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín: a Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 5 Months – 59 Months
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food	1 g orally on weekdays during 11 weeks
DIETARY_SUPPLEMENT	placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-08-06
• Last updated: 2013-08-06

Locations

1 site across 1 country: Colombia