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

NCT01917032 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-08-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • CES University

    lead OTHER

Principal Investigators

  • Cristian Vargas, MD · CES University

  • Juliana Orozco, Nutricionist · CES University

  • Juliana Sánchez, Dentist · CES University

  • Liliana Montoya, Epidemiology · CES University

  • Javier Chica, Veterinarian · CES University

  • Maylen Rojas, Epidemiology · CES University

  • Óscar Villada, MD · CES University

  • Alejandro Díaz, Pediatrist · CES University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917032 on ClinicalTrials.gov